CompletedNCT03793556Updated Mar 31, 2020Results posted

Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor

An interventional study of GERDOFF® + Omeprazole and Omeprazole in Gastro-oesophageal Reflux Disease, sponsored by SOFAR S.p.A.. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-31.

Sponsored by SOFAR S.p.A. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The aim of the present study was to evaluate the effect of a 6-weeks treatment of a CE-marked combination oral formulation of hyaluronic acid with chondroitin sulphate and aluminium hydroxide (GERDOFF®), in addition to proton pump inhibitors (PPI) at the standard dose, versus PPI only, in patients with first diagnosed clinical presentation of extra-esophageal GERD symptoms.

The investigators verified the reduction of symptoms frequency, using a Likert questionnaire, and severity, using the Reflux Symptom Index (RSI) questionnaire, to evaluate the proportion of Responders and Non-Responder patients in these two groups after 6 weeks of treatment, compared to baseline. Moreover investigators evaluated the persistence of effects of GERDOFF® + PPI treatment on extraesophageal symptoms, after a 12-weeks follow up, only in responder patients.

Read the detailed description

Cough, hoarseness, prolonged voice lowering, and vocal timbre modification, without any documentable cause, are considered as minor disorders for which patients do not receive adequate attention. These disorders may represent extra-esophageal manifestations of gastro-oesophagea reflux. Accurate diagnosis and gastro-oesophageal reflux therapy have been proved as useful to improve patients' quality of life.

The aim of the present study was to evaluate, in first diagnosed patients presenting with upper symptoms associated with GERD, the effect of a 6-week treatment with a combination based on CS, HA and aluminium hydroxide (Gerdoff®), co-administered with a treatment with PPIs, compared to treatment with PPIs as monotherapy, i.e. to verify, in patients treated with the combination of the two products, the reduction in symptoms frequency by means of a Likert questionnaire and the severity of upper symptoms by means of the Reflux Symptom Index (RSI) questionnaire, and to collect safety data. After 6 weeks of treatment, patients included in the two groups were then classified as responders or non-responders. Responder patients were defined as those patients that, at the 6th week of treatment, reached a RSI score decreased for at least 50% compared to baseline and an absolute value \< 13.

Furthermore, the maintenance of the effect of treatment on the extra-oesophageal symptoms was evaluated after a period of follow-up lasting 12 weeks, which could be entered only by responder patients randomised in the Gerdoff®-PPI arm. Patients included in the follow-up period were randomised to receive Gerdoff® or no treatment (control group). Safety data were also evaluated in the group of patients that continued in the follow-up period.

Conditions studied

Gastro-oesophageal Reflux Disease

Browse trials for

Gastroesophageal Reflux 1,063

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female subjects aged ≥ 18 years;
First diagnosis of GERD with upper symptoms, made on a clinical basis and confirmed by an ENT and/or confirmed by a Gastroenterologist using a RSI questionnaire;
Presence of extra-oesophageal symptoms associated with GERD;
RSI score ≥ 20;
Patients not pre-treated with PPIs, even for problems different from GERD, and/or with medical devices and/or similar products (e.g. antacid alginates etc..) in the last 4 weeks;
Cooperative patients, able to understand and adhere to the study procedures;
Patient able to freely give their written informed consent to study participation;
Patients that freely gave the consent to management of personal data related to the study.

Exclusion criteria

Exclusion Criteria:

Known infective oesophagitis or oesophagitis due to acid or alkaline substances;
Acute or chronic rhinosinusitis;
Chronic bronchitis;
Known Zollinger-Ellison syndrome, hiatal hernia greater than 3 cm and Barrett oesophagus;
Ongoing neoplasias;
Uncontrolled diabetes;
Patients with impaired liver function;
Patients with rare hereditary problems of galactose intolerance;
Patients that, based on Investigator's opinion, could not take part in the study due to other diseases or concomitant therapies, such as the intake of atazanavir, nelfinavir, clopidogrel, posaconazole and erlotinib (as recommended in the Summary of Product Characteristics of Gerdoff®);
Patients with deficiency of Lapp lactase;
Patients with syndrome of glu-gal malabsorption;
Patients with hypersensitivity to omeprazole, substitute benzymidazolic or any of the excipients;
Patients already in treatment with PPIs or similar products;
Chronic use of drugs that interfere with the salivary secretion (e.g. anti-histamines or inhaled steroids);
Abuse of drug or alcohol;
Inability of the subject to adequately express his/her disturbances;
Patients with planned or ascertained pregnancy or that did not adopt an accepted contraceptive method;
Lactating patients.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 72 participants (actual)

Study arms

Experimental
GERDOFF® + omeprazole
GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).
Device: GERDOFF® + Omeprazole
Active comparator
Omeprazole
Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).
Drug: Omeprazole

Interventions

DeviceGERDOFF® + Omeprazole
GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg + Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).
Also known as: GERDOFF®
DrugOmeprazole
Omeprazole, 2 capsules 20 mg, once a day before breakfast
Also known as: Omeprazen

What researchers measure

Primary outcomes

Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire
After 6 weeks of treatment, the changes from baseline in the score of Reflux Symptom Index questionnaire were evaluated to verify the effects of treatments on high symptoms. The RSI questionnaire examines 9 items that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).
Time frame: In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)

Secondary outcomes

Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed
Total score of the Reflux Symptom Index questionnaire assessed in all time-points. The RSI questionnaire examines 9 items, that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).
Time frame: In baseline Visit, Visit 2 (after 1 week), Visit 3 (after 3 weeks) and Visit 4 (after 6 weeks of treatment)
Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4
The Reflux Symptom Index questionnaire examines 9 items, including hoarseness or vocal problem that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance
The Reflux Symptom Index questionnaire examines 9 items, including throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4
The Reflux Symptom Index questionnaire examines 9 items, including excess of mucus in the throat or retrosternal fall of secretions that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4
The Reflux Symptom Index questionnaire examines 9 items, including difficulty in swallowing food, fluids or pills that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying
The Reflux Symptom Index questionnaire examines 9 items, including cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4
The Reflux Symptom Index questionnaire examines 9 items, including difficulty in breathing or episodes of choking that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4
The Reflux Symptom Index questionnaire examines 9 items, including problematic or troublesome cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4
The Reflux Symptom Index questionnaire examines 9 items, including sensation of something blocked or mass in the throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4
The Reflux Symptom Index questionnaire examines 9 items, including stomach burning, thoracic pain, poor digestion of gastric acid that moves upright that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Number of Responders V4
A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value \< 13 on the RSI questionnaire.
Time frame: At visit 4 after 6 weeks of treatment
Number of Responders V6
Responder patients of Group Gerdoff® + omeprazole were randomly assigned to receive a treatment with Gerdoff®-one tablet three times daily- All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks. A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value \< 13 on the RSI questionnaire.
Time frame: In the Visit 6 at the end of follow-up
Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4
The Likert scale examines 9 symptoms, to be scored from 0 to 4, with a higher score indication a higher frequency of the symptom (i.e. 0=never, 1=occasionally, 2=sometimes, 3= often, 4=Always); The Likert scale scores of single items are as following: 1. Hoarseness or vocal problem 0 1 2 3 4 2. Throat clearance 0 1 2 3 4 3. Excess of mucus in the throat or retrosternal fall of secretions 0 1 2 3 4 4. Difficulty in swallowing food, fluids or pills 0 1 2 3 4 5. Cough after the meal or after lying 0 1 2 3 4 6. Difficulty in breathing or episodes of choking 0 1 2 3 4 7. Problematic or troublesome cough 0 1 2 3 4 8. Sensation of something blocked or mass in the throat 0 1 2 3 4 9. Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright 0 1 2 3 4. Subscales are summarized to compute a total score (total score ranges from 0-36). The mean values of Likert scale total score are reported.
Time frame: At baseline and in the visit 4
Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire
The Reflux Symptom Index questionnaire examines 9 items, to be scored from 0 to 5, with a higher score indication a higher severity of the symptom (range of total score: 0-45).
Time frame: At visit 4 after weeks of treatment
Use of Rescue Medication (Omeprazole) During the Treatment
In the first 6 weeks of treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug and the comparison between groups was performed using the Fisher's exact test.
Time frame: From baseline to visit 4
Use of Rescue Medication (Omeprazole) During the Follow-up
During the follow-up, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.
Time frame: In the Visit 6 after 12 weeks from baseline
Use of Rescue Medication (Other Than Omeprazole) During Treatment
During treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.
Time frame: From baseline to visit 4
Patients'Satisfaction
This evaluation was expressed with a semi-quantitative ordinal scale: 0 = low, 1 = discrete, 2 = good, 3 = excellent).
Time frame: At visit 4 after weeks of treatment

Results

Posted Mar 18, 2020

Participant flow

A first specialist visit was performed by an ENT as per clinical practice based on patient's symptoms. Patients sent by the ENT should not have been pre-treated with PPIs and/or medical devices and/or similar products. The diagnosis was confirmed by the Gastroenterologist Investigator who recruited patients.

Participant flow — Overall Study
Milestone	GERDOFF® + Omeprazole	Omeprazole
Started	35	36
Completed	22	34
Not completed	13	2
Withdrew: Withdrawal by subject	12	1
Withdrew: Lost to follow-up	1	1

Outcome measures

PrimaryChange From Baseline to Visit V4 of the Total Score of RSI Questionnaire

After 6 weeks of treatment, the changes from baseline in the score of Reflux Symptom Index questionnaire were evaluated to verify the effects of treatments on high symptoms. The RSI questionnaire examines 9 items that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).

Time frame:: In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)
Reported as:: Mean · Score on a scale

Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire
Score on a scale	GERDOFF® + Omeprazole	Omeprazole
Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire	-16.2 ± 7.45	-13.7 ± 10.58

Statistical analysis

GERDOFF® + Omeprazole vs Omeprazole · Unpaired t test · p = 0.276 · Mean difference (final values): -2.5 · 95% CI -7.03 to 2.04

SecondaryTotal Score of Reflux Symptom Index Questionnaire in All Time-points Assessed

Total score of the Reflux Symptom Index questionnaire assessed in all time-points. The RSI questionnaire examines 9 items, that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).

Time frame:: In baseline Visit, Visit 2 (after 1 week), Visit 3 (after 3 weeks) and Visit 4 (after 6 weeks of treatment)
Reported as:: Mean · score on a scale

Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed
score on a scale	GERDOFF® + Omeprazole	Omeprazole
Baseline	24.2 ± 5.18	26.0 ± 4.96
Visit 2	15.3 ± 7.86	19.6 ± 7.20
Visit 3	12.9 ± 7.77	15.3 ± 8.08
Visit 4	7.9 ± 6.04	12.3 ± 8.98

Statistical analysis

GERDOFF® + Omeprazole vs Omeprazole · ANOVA · p = 0.0157The ANOVA model examined the entire curve profile.

SecondaryScore of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including hoarseness or vocal problem that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:: At baseline and in the visit 4, after 6 weeks of treatment
Reported as:: Mean · score on a scale

Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4
score on a scale	GERDOFF® + Omeprazole	Omeprazole
Baseline	3.2 ± 1.35	2.8 ± 1.54
Visit 4	1.1 ± 1.33	1.6 ± 1.54

SecondaryScore of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance

The Reflux Symptom Index questionnaire examines 9 items, including throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:: At baseline and in the visit 4, after 6 weeks of treatment
Reported as:: Mean · score on a scale

Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance
score on a scale	GERDOFF® + Omeprazole	Omeprazole
Baseline	3.4 ± 1.22	3.6 ± 1.00
Visit 4	1.4 ± 1.39	1.8 ± 1.37

SecondaryScore of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including excess of mucus in the throat or retrosternal fall of secretions that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:: At baseline and in the visit 4, after 6 weeks of treatment
Reported as:: Mean · score on a scale

Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4
score on a scale	GERDOFF® + Omeprazole	Omeprazole
Baseline	2.7 ± 1.76	2.8 ± 1.77
Visit 4	1.4 ± 1.31	1.9 ± 1.61

SecondaryScore of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including difficulty in swallowing food, fluids or pills that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:: At baseline and in the visit 4, after 6 weeks of treatment
Reported as:: Mean · score on a scale

Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4
score on a scale	GERDOFF® + Omeprazole	Omeprazole
Baseline	1.9 ± 1.66	1.9 ± 1.84
Visit 4	0.4 ± 0.71	0.6 ± 0.94

SecondaryScore of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying

The Reflux Symptom Index questionnaire examines 9 items, including cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:: At baseline and in the visit 4, after 6 weeks of treatment
Reported as:: Mean · score on a scale

Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying
score on a scale	GERDOFF® + Omeprazole	Omeprazole
Baseline	2.5 ± 1.76	3.3 ± 1.44
Visit 4	0.7 ± 1.01	1.7 ± 1.47

SecondaryScore of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including difficulty in breathing or episodes of choking that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:: At baseline and in the visit 4, after 6 weeks of treatment
Reported as:: Mean · score on a scale

Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4
score on a scale	GERDOFF® + Omeprazole	Omeprazole
Baseline	1.5 ± 1.60	1.9 ± 1.69
Visit 4	0.5 ± 1.15	0.6 ± 0.97

SecondaryScore of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including problematic or troublesome cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:: At baseline and in the visit 4, after 6 weeks of treatment
Reported as:: Mean · score on a scale

Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4
score on a scale	GERDOFF® + Omeprazole	Omeprazole
Baseline	2.5 ± 1.65	3.7 ± 1.19
Visit 4	0.8 ± 1.17	1.5 ± 1.54

SecondaryScore of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including sensation of something blocked or mass in the throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:: At baseline and in the visit 4, after 6 weeks of treatment
Reported as:: Mean · score on a scale

Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4
score on a scale	GERDOFF® + Omeprazole	Omeprazole
Baseline	3.0 ± 1.52	2.6 ± 1.75
Visit 4	0.8 ± 1.08	1.6 ± 1.59

SecondaryScore of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including stomach burning, thoracic pain, poor digestion of gastric acid that moves upright that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:: At baseline and in the visit 4, after 6 weeks of treatment
Reported as:: Mean · Score on a scale

Score of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4
Score on a scale	GERDOFF® + Omeprazole	Omeprazole
Baseline	3.4 ± 1.56	3.5 ± 1.83
Visit 4	0.8 ± 1.08	3.5 ± 1.83

SecondaryNumber of Responders V4

A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value \< 13 on the RSI questionnaire.

Time frame:: At visit 4 after 6 weeks of treatment
Reported as:: Count of participants · Participants

Number of Responders V4
Participants	GERDOFF® + Omeprazole	Omeprazole
Yes	23	20
No	8	16

Statistical analysis

GERDOFF® + Omeprazole vs Omeprazole · Chi-squared · p = 0.0496

SecondaryNumber of Responders V6

Responder patients of Group Gerdoff® + omeprazole were randomly assigned to receive a treatment with Gerdoff®-one tablet three times daily- All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks. A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value \< 13 on the RSI questionnaire.

Time frame:: In the Visit 6 at the end of follow-up
Reported as:: Count of participants · Participants

Number of Responders V6
Participants	GERDOFF® + Omeprazole	No Treated
yes	9	7
No	0	1

SecondaryScore of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4

The Likert scale examines 9 symptoms, to be scored from 0 to 4, with a higher score indication a higher frequency of the symptom (i.e. 0=never, 1=occasionally, 2=sometimes, 3= often, 4=Always); The Likert scale scores of single items are as following: 1. Hoarseness or vocal problem 0 1 2 3 4 2. Throat clearance 0 1 2 3 4 3. Excess of mucus in the throat or retrosternal fall of secretions 0 1 2 3 4 4. Difficulty in swallowing food, fluids or pills 0 1 2 3 4 5. Cough after the meal or after lying 0 1 2 3 4 6. Difficulty in breathing or episodes of choking 0 1 2 3 4 7. Problematic or troublesome cough 0 1 2 3 4 8. Sensation of something blocked or mass in the throat 0 1 2 3 4 9. Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright 0 1 2 3 4. Subscales are summarized to compute a total score (total score ranges from 0-36). The mean values of Likert scale total score are reported.

Time frame:: At baseline and in the visit 4
Reported as:: Mean · Score on a scale

Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4
Score on a scale	GERDOFF® + Omeprazole	Omeprazole
Baseline	19.0 ± 4.301	21 ± 4.557
Visit 4	7.4 ± 5.667	11.6 ± 8.083

Statistical analysis

GERDOFF® + Omeprazole vs Omeprazole · ANOVA · p = 0.0065

SecondaryPresence of Upper Symptoms at Visit 4, Using the RSI Questionnaire

The Reflux Symptom Index questionnaire examines 9 items, to be scored from 0 to 5, with a higher score indication a higher severity of the symptom (range of total score: 0-45).

Time frame:: At visit 4 after weeks of treatment
Reported as:: Count of participants · Participants

Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire
Participants	GERDOFF® + Omeprazole	Omeprazole
Missing	1	4
1 symptom	7	2
2 symptoms	6	9
3 symptoms	13	11
4 symptoms	4	7
5 symptoms	0	2
6 symptoms	0	1

SecondaryUse of Rescue Medication (Omeprazole) During the Treatment

In the first 6 weeks of treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug and the comparison between groups was performed using the Fisher's exact test.

Time frame:: From baseline to visit 4
Reported as:: Count of participants · Participants

Use of Rescue Medication (Omeprazole) During the Treatment
Participants	GERDOFF® + Omeprazole	Omeprazole
Yes	24	28
No	11	8

SecondaryUse of Rescue Medication (Omeprazole) During the Follow-up

During the follow-up, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.

Time frame:: In the Visit 6 after 12 weeks from baseline
Reported as:: Count of participants · Participants

Use of Rescue Medication (Omeprazole) During the Follow-up
Participants	GERDOFF® + Omeprazole	No Treated
Yes	7	5
No	2	3

SecondaryUse of Rescue Medication (Other Than Omeprazole) During Treatment

During treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.

Time frame:: From baseline to visit 4
Reported as:: Count of participants · Participants

Use of Rescue Medication (Other Than Omeprazole) During Treatment
Participants	GERDOFF® + Omeprazole	Omeprazole
Yes	0	4
No	31	32

SecondaryPatients'Satisfaction

This evaluation was expressed with a semi-quantitative ordinal scale: 0 = low, 1 = discrete, 2 = good, 3 = excellent).

Time frame:: At visit 4 after weeks of treatment
Reported as:: Count of participants · Participants

Patients'Satisfaction
Participants	GERDOFF® + Omeprazole	Omeprazole
Missing	1	0
Low	3	1
Discrete	1	7
Good	11	11
Excellent	15	17

Adverse events

Collected over During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
GERDOFF® + Omeprazole	0/35 (0%)	0/35 (0%)	14/35 (40%)
Omeprazole	0/36 (0%)	1/36 (2.8%)	12/36 (33.3%)

Most frequent serious events

Most frequent serious events
Event	GERDOFF® + Omeprazole	Omeprazole
Atrial fibrillationCardiac disorders	0/35	1/36

Most frequent other events

Showing 10 of 26

Most frequent other events
Event	GERDOFF® + Omeprazole	Omeprazole
NauseaGastrointestinal disorders	4/35	3/36
Flu-like symptomsGeneral disorders	3/35	2/36
MigraineNervous system disorders	2/35	0/36
PyrexiaGeneral disorders	0/35	2/36
DiarrheaGastrointestinal disorders	0/35	2/36
NasopharyngitisInfections and infestations	1/35	2/36
Red blood cell sedimentation rate increasedInvestigations	1/35	0/36
C-reactive protein increased subjects affected / exposedInvestigations	1/35	0/36
HypersensitivityImmune system disorders	1/35	0/36
BronchospasmRespiratory, thoracic and mediastinal disorders	1/35	0/36

Baseline characteristics

Age, Continuous
Age, Continuous(years)	GERDOFF® + Omeprazole	Omeprazole	Total
Median	46.0 (20 to 86)	45.0 (20 to 76)	46.0 (20 to 86)

Sex: Female, Male
Sex: Female, Male(Participants)	GERDOFF® + Omeprazole	Omeprazole	Total
Female	22	32	54
Male	13	4	17

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	GERDOFF® + Omeprazole	Omeprazole	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	35	36	71
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Patients with simultaneous symptoms
Patients with simultaneous symptoms(participants)	GERDOFF® + Omeprazole	Omeprazole	Total
1 symptom	2	3	5
2 symptoms	5	1	6
3 symptoms	9	6	15
4 symptoms	11	17	28
5 symptoms	5	5	10
6 symptoms	2	3	5
7 symptoms	1	1	2

Hoarseness or vocal problem
Hoarseness or vocal problem(participants)	GERDOFF® + Omeprazole	Omeprazole	Total
yes	21	18	39
no	14	18	32

Throat clearance
Throat clearance(participants)	GERDOFF® + Omeprazole	Omeprazole	Total
yes	18	23	41
no	17	13	30

Excess of mucus in the throat or retrosternal fall of secretions
Excess of mucus in the throat or retrosternal fall of secretions(participants)	GERDOFF® + Omeprazole	Omeprazole	Total
yes	14	15	29
no	21	21	42

Difficulty in swallowing food, fluids or pills
Difficulty in swallowing food, fluids or pills(participants)	GERDOFF® + Omeprazole	Omeprazole	Total
yes	7	7	14
no	28	29	57

8 further baseline measures are reported on the registry.

Study locations

1 site

dr Alessandro Repici
Rozzano, MI 20089, Italy

References and documents

Study documents

Protocol and statistical analysis plan · Feb 20, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03793556
Lead sponsor: SOFAR S.p.A.
Responsible party: Sponsor
First posted: Jan 4, 2019
Start date: May 5, 2017
Primary completion: Sep 20, 2018
Completion: Dec 11, 2018
Results posted: Mar 18, 2020
Last update: Mar 31, 2020

Study contacts

Alessandro Repici, MD

principal investigator · Istituto Clinico Humanitas

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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