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CompletedNCT02704091ADIASEUpdated Nov 5, 2020Results posted

Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults

A Phase 4 interventional study of Smecta and Smecta placebo in Acute Diarrhoea, sponsored by Ipsen. Completed at 71 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-05.

Sponsored by Ipsen · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
858
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to demonstrate that diosmectite efficacy is superior to placebo regarding time to recovery of an acute diarrhoea episode presumed of infectious origin in adult subjects.

02

Conditions studied

  • Acute Diarrhoea

Browse trials for

03

In context

Diarrhea

852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.

This study's enrollment of 858 is above the median of 136 across 713 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

  • Provision of written informed consent prior to any study related procedures
  • Male or female subject (outpatient) legally considered as an adult (age of majority). In Czech Republic, the upper limit of age will be 70 years inclusive. In Egypt, the upper limit of age will be 60 years inclusive.
  • Subject has a diagnosis of acute diarrhoea presumed of infectious origin, defined as the passage of 3 or more unformed loose or watery stools (rated according to the Bristol scale) per day within the last 48 hours without associated alarm symptoms
  • Subject has, usually, normal bowel habits (Rome III criteria), i.e. at least 3 stools per week and no more than 3 stools per day
  • Subject must be willing and able to comply with study restrictions and willing to return to the clinic for the follow up evaluation(s) as specified in the protocol.

Exclusion criteria related to the acute diarrhoea episode:

  • At least one of the following alarm symptoms

    • Bloody diarrhoea*,
    • pus in the stools*,
    • fever ≥38°C*,
    • moderate or severe dehydration according to World Health Organisation (WHO) definition, requiring intravenous (IV) rehydration*,
    • repeated vomiting*,
    • persistent abdominal pain* *These symptoms are considered as alarm symptoms
  • other episode of acute watery diarrhoea within the previous 30 days,
  • persistent diarrhoea, defined as acutely starting episode of diarrhoea lasting more than 14 days,
  • history of chronic diarrhoea (Rome III criteria); i.e. 3 or more loose or watery stools per day for at least 12 weeks, consecutive or not, in the preceding 12 months,
  • traveller's diarrhoea defined as a diarrhoeal episode due to contamination experienced by subjects having travelled in at risk countries, or coming from abroad and experiencing locally an acute diarrhoea episode, occurring usually within the first 2 weeks of the stay in a foreign environment.

Exclusion criteria

Exclusion criteria related to drugs:

  • Diarrhoea suspected to be induced by drug for example:

    • antibiotic therapy, including Clostridium difficile-induced diarrhoea, within 1 week before entry in the study,
    • laxative agent
    • thyroid hormone (at a nonstabilised dosing),
    • intake of other prohibited drugs (as specified in the protocol)
  • anti-diarrhoeal agent intake during the last month,
  • any subject requiring repeated intake of a drug with a narrow therapeutic margin (as specified in the protocol),
  • history of hypersensitivity to diosmectite or its excipients or placebo components,
  • subject likely to require treatment during the study with drugs that are not permitted by the study protocol (for example, antibiotic agent, anti-diarrhoeal agent, antiemetic drug, antispasmodic drug),
  • use of any investigational medication within the last 30 days before entering this study,
  • subject who previously entered in a clinical study within the past 30 days.

Other digestive exclusion criteria:

  • History of gastric or intestinal resection, vagotomy,
  • known digestive malabsorption disease, including coeliac disease
  • known lactose intolerance,
  • any suspicion of abdominal surgery need,
  • known inflammatory bowel disease.

Other exclusion criteria:

  • Known Human immunodeficiency virus (HIV) positive status,
  • known or suspected immunosuppression,
  • known severe renal insufficiency (including e-GFR not less than 45 mL/min) or hepatic insufficiency,
  • known endocrine disease or Type II Diabetes Mellitus with HBA1c more than 8,5% or insulin-dependent diabetes,
  • history of, or known current, problems with alcohol abuse and/or known drug addiction (cocaine, heroin, hashish...),
  • previous enrolment in this study,
  • any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
  • Pregnant or lactating women
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
858 participants (actual)

Study arms

  • Active comparator
    Smecta

    2 sachets, three times a day (TID), during 5 to 9 days

    Drug: Smecta

  • Placebo comparator
    Smecta placebo

    2 sachets of placebo, TID, during 5 to 9 days

    Drug: Smecta placebo

Interventions

  • DrugSmecta

    Also known as: Diosmectite Beaufour

  • DrugSmecta placebo
06

What researchers measure

Primary outcomes

  1. Time to Recovery

    Time to recovery was defined as the time from the first study treatment intake recorded in the electronic case report form (eCRF) to the first formed stool followed by a non-watery stool, recorded in the DEB. Results are presented as median time to recovery, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).

    Time frame: From randomisation (Day 1) up to Day 9

Secondary outcomes

  1. Time From Diarrhoea Onset to Recovery

    The event of diarrhoea onset (i.e. loose or watery stool) was recorded in the eCRF and the event of recovery (i.e. first formed stool followed by a non-watery stool) was recorded in the DEB. Results are presented as median time from diarrhoea onset to recovery, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).

    Time frame: From randomisation (Day 1) up to Day 9

  2. Time From Diarrhoea Onset to First Formed Stool

    The event of diarrhoea onset (i.e. loose or watery stool) was recorded in the eCRF and the event of first formed stool was recorded in the DEB. Results are presented as median time from diarrhoea onset to first formed stool, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn with no formed stool or ending the study with no formed stool were censored at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).

    Time frame: From randomisation (Day 1) up to Day 9

  3. Time From the First Study Treatment Intake to the Last Watery Stool

    The event of first study treatment intake was recorded in the eCRF and the event of last watery stool was recorded in the DEB. Results are presented as median time from first study treatment intake to last watery stool, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn with no watery stool or ending the study with no watery stool were censored at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).

    Time frame: From randomisation (Day 1) up to Day 9

  4. Number of Stools, Per 12-Hour Period

    Number of stools, per 12-hour period, was recorded in the DEB.

    Time frame: From randomisation (Day 1) up to Day 9

  5. Number of Watery Stools, Per 12-Hour Period

    Number of watery stools, per 12-hour period, was recorded in the DEB.

    Time frame: From randomisation (Day 1) up to Day 9

  6. Percentage of Participants With Associated Symptoms, Per 12-Hour Period

    Percentage of participants with associated symptoms (at least 1 symptom of nausea, vomiting, abdominal pain or anal irritation) per 12-hour period is presented. Nausea, vomiting, abdominal pain and anal irritation were recorded in the DEB.

    Time frame: From randomisation (Day 1) up to Day 9

  7. Abdominal Pain Intensity Scores, Per 12-Hour Period

    Abdominal pain intensity per 12-hour period was recorded in the DEB. Abdominal pain intensity was rated with a 5-point ordinal scale: 0 = absent, 1= mild, 2 =moderate, 3 = severe, 4= very severe. Higher scores indicate a worse outcome. The median abdominal pain intensity score for each 12-hour period is presented.

    Time frame: From randomisation (Day 1) up to Day 9

07

Results

Posted Apr 24, 2020

Participant flow

The study enrolled adult participants with a recent episode of acute diarrhoea presumed of infectious origin, defined as the passage of 3 or more unformed (loose or watery) stools per day without alarm symptoms within the first 48 hours. Participants were randomised at 62 study centres in Algeria, Czech Republic, Egypt, Lebanon, Poland and Tunisia.

Participant flow — Overall Study
MilestoneDiosmectitePlacebo
Started430423
Completed402400
Not completed2823
Withdrew: Adverse event43
Withdrew: Protocol violation53
Withdrew: Consent withdrawn44
Withdrew: Lost to follow-up135
Withdrew: Other28

Outcome measures

PrimaryTime to Recovery

Time to recovery was defined as the time from the first study treatment intake recorded in the electronic case report form (eCRF) to the first formed stool followed by a non-watery stool, recorded in the DEB. Results are presented as median time to recovery, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).

Time frame:
From randomisation (Day 1) up to Day 9
Reported as:
Median · Hours
Time to Recovery
HoursDiosmectitePlacebo
Time to Recovery66.0 (53.7 to 71.0)68.6 (57.5 to 77.8)
Statistical analysis
  • Diosmectite vs Placebo · Wilcoxon-Gehan test · p = =0.2524
SecondaryTime From Diarrhoea Onset to Recovery

The event of diarrhoea onset (i.e. loose or watery stool) was recorded in the eCRF and the event of recovery (i.e. first formed stool followed by a non-watery stool) was recorded in the DEB. Results are presented as median time from diarrhoea onset to recovery, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).

Time frame:
From randomisation (Day 1) up to Day 9
Reported as:
Median · Hours
Time From Diarrhoea Onset to Recovery
HoursDiosmectitePlacebo
Time From Diarrhoea Onset to Recovery91.0 (82.5 to 107.0)92.2 (84.2 to 102.8)
Statistical analysis
  • Diosmectite vs Placebo · Gehan-Wilcoxon test · p = =0.3511
SecondaryTime From Diarrhoea Onset to First Formed Stool

The event of diarrhoea onset (i.e. loose or watery stool) was recorded in the eCRF and the event of first formed stool was recorded in the DEB. Results are presented as median time from diarrhoea onset to first formed stool, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn with no formed stool or ending the study with no formed stool were censored at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).

Time frame:
From randomisation (Day 1) up to Day 9
Reported as:
Median · Hours
Time From Diarrhoea Onset to First Formed Stool
HoursDiosmectitePlacebo
Time From Diarrhoea Onset to First Formed Stool84.3 (77.5 to 94.2)84.6 (79.8 to 91.0)
Statistical analysis
  • Diosmectite vs Placebo · Gehan-Wilcoxon test · p = =0.7285
SecondaryTime From the First Study Treatment Intake to the Last Watery Stool

The event of first study treatment intake was recorded in the eCRF and the event of last watery stool was recorded in the DEB. Results are presented as median time from first study treatment intake to last watery stool, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn with no watery stool or ending the study with no watery stool were censored at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).

Time frame:
From randomisation (Day 1) up to Day 9
Reported as:
Median · Hours
Time From the First Study Treatment Intake to the Last Watery Stool
HoursDiosmectitePlacebo
Time From the First Study Treatment Intake to the Last Watery Stool56.2 (44.6 to 66.2)60.0 (52.8 to 68.8)
Statistical analysis
  • Diosmectite vs Placebo · Gehan-Wilcoxon test · p = =0.1807
SecondaryNumber of Stools, Per 12-Hour Period

Number of stools, per 12-hour period, was recorded in the DEB.

Time frame:
From randomisation (Day 1) up to Day 9
Reported as:
Median · Stools
Number of Stools, Per 12-Hour Period
StoolsDiosmectitePlacebo
0 - 12 hours3.0 (0 to 11)3.0 (0 to 14)
12 - 24 hours2.0 (0 to 7)2.0 (0 to 7)
24 - 36 hours1.0 (0 to 8)2.0 (0 to 19)
36 - 48 hours1.0 (0 to 7)1.0 (0 to 6)
48 - 60 hours1.0 (0 to 7)1.0 (0 to 9)
60 - 72 hours1.0 (0 to 6)1.0 (0 to 7)
72 - 84 hours1.0 (0 to 12)1.0 (0 to 7)
84 - 96 hours1.0 (0 to 6)1.0 (0 to 7)
96 - 108 hours1.0 (0 to 5)1.0 (0 to 7)
108 - 120 hours1.0 (0 to 5)1.0 (0 to 6)
120 - 132 hours1.0 (0 to 4)1.0 (0 to 6)
132 - 144 hours1.0 (0 to 6)1.0 (0 to 4)
144 - 156 hours1.0 (0 to 4)1.0 (0 to 6)
156 - 168 hours1.0 (0 to 4)1.0 (0 to 5)
168 - 180 hours1.0 (0 to 5)1.0 (0 to 4)
180 - 192 hours1.0 (0 to 5)1.0 (0 to 5)
192 - 204 hours1.0 (1 to 4)1.0 (0 to 4)
204 - 216 hours—1.0 (1 to 1)
Statistical analysis
  • Diosmectite vs Placebo · ANCOVA · p = 0.4294 · Least squares (ls) mean difference: -0.04 · 95% CI -0.15 to 0.07
SecondaryNumber of Watery Stools, Per 12-Hour Period

Number of watery stools, per 12-hour period, was recorded in the DEB.

Time frame:
From randomisation (Day 1) up to Day 9
Reported as:
Median · Stools
Number of Watery Stools, Per 12-Hour Period
StoolsDiosmectitePlacebo
0 - 12 hours3.0 (0 to 11)3.0 (0 to 14)
12 - 24 hours1.0 (0 to 7)1.0 (0 to 7)
24 - 36 hours0.0 (0 to 8)1.0 (0 to 19)
36 - 48 hours0.0 (0 to 7)0.0 (0 to 6)
48 - 60 hours0.0 (0 to 7)0.0 (0 to 9)
60 - 72 hours0.0 (0 to 6)0.0 (0 to 7)
72 - 84 hours0.0 (0 to 10)0.0 (0 to 7)
84 - 96 hours0.0 (0 to 6)0.0 (0 to 7)
96 - 108 hours0.0 (0 to 5)0.0 (0 to 7)
108 - 120 hours0.0 (0 to 5)0.0 (0 to 6)
120 - 132 hours0.0 (0 to 4)0.0 (0 to 5)
132 - 144 hours0.0 (0 to 6)0.0 (0 to 4)
144 - 156 hours0.0 (0 to 3)0.0 (0 to 5)
156 - 168 hours0.0 (0 to 4)0.0 (0 to 5)
168 - 180 hours0.0 (0 to 5)0.0 (0 to 4)
180 - 192 hours0.0 (0 to 5)0.0 (0 to 5)
192 - 204 hours0.0 (0 to 4)0.0 (0 to 3)
204 - 216 hours—0.0 (0 to 0)
Statistical analysis
  • Diosmectite vs Placebo · ANCOVA · p = 0.0465 · Ls mean difference: -0.12 · 95% CI -0.24 to -0.00
SecondaryPercentage of Participants With Associated Symptoms, Per 12-Hour Period

Percentage of participants with associated symptoms (at least 1 symptom of nausea, vomiting, abdominal pain or anal irritation) per 12-hour period is presented. Nausea, vomiting, abdominal pain and anal irritation were recorded in the DEB.

Time frame:
From randomisation (Day 1) up to Day 9
Reported as:
Number · Percentage of participants
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
Percentage of participantsDiosmectitePlacebo
0 - 12 hours76.376.4
12 - 24 hours67.164.6
24 - 36 hours56.254.2
36 - 48 hours44.845.6
48 - 60 hours34.935.4
60 - 72 hours28.728.8
72 - 84 hours24.322.0
84 - 96 hours21.620.6
96 - 108 hours20.624.0
108 - 120 hours18.624.9
120 - 132 hours18.427.9
132 - 144 hours12.621.4
144 - 156 hours10.519.2
156 - 168 hours8.516.1
168 - 180 hours8.611.8
180 - 192 hours8.29.8
192 - 204 hours9.710.5
204 - 216 hours5.90.0
SecondaryAbdominal Pain Intensity Scores, Per 12-Hour Period

Abdominal pain intensity per 12-hour period was recorded in the DEB. Abdominal pain intensity was rated with a 5-point ordinal scale: 0 = absent, 1= mild, 2 =moderate, 3 = severe, 4= very severe. Higher scores indicate a worse outcome. The median abdominal pain intensity score for each 12-hour period is presented.

Time frame:
From randomisation (Day 1) up to Day 9
Reported as:
Median · Scores on a scale
Abdominal Pain Intensity Scores, Per 12-Hour Period
Scores on a scaleDiosmectitePlacebo
0 - 12 hours1.0 (0 to 4)1.0 (0 to 4)
12 - 24 hours1.0 (0 to 4)1.0 (0 to 4)
24 - 36 hours0.0 (0 to 4)0.0 (0 to 4)
36 - 48 hours0.0 (0 to 4)0.0 (0 to 4)
48 - 60 hours0.0 (0 to 4)0.0 (0 to 4)
60 - 72 hours0.0 (0 to 4)0.0 (0 to 4)
72 - 84 hours0.0 (0 to 4)0.0 (0 to 4)
84 - 96 hours0.0 (0 to 4)0.0 (0 to 4)
96 - 108 hours0.0 (0 to 3)0.0 (0 to 4)
108 - 120 hours0.0 (0 to 3)0.0 (0 to 4)
120 - 132 hours0.0 (0 to 4)0.0 (0 to 4)
132 - 144 hours0.0 (0 to 2)0.0 (0 to 4)
144 - 156 hours0.0 (0 to 3)0.0 (0 to 4)
156 - 168 hours0.0 (0 to 3)0.0 (0 to 4)
168 - 180 hours0.0 (0 to 3)0.0 (0 to 4)
180 - 192 hours0.0 (0 to 2)0.0 (0 to 4)
192 - 204 hours0.0 (0 to 4)0.0 (0 to 4)
204 - 216 hours0.0 (0 to 1)0.0 (0 to 0)

Adverse events

Collected over Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Diosmectite0/430 (0%)1/430 (0.2%)29/430 (6.7%)
Placebo0/421 (0%)1/421 (0.2%)32/421 (7.6%)
Most frequent serious events
Most frequent serious events
EventDiosmectitePlacebo
ColitisGastrointestinal disorders0/4301/421
DehydrationMetabolism and nutrition disorders0/4301/421
Abdominal painGastrointestinal disorders1/4300/421
DiarrhoeaGastrointestinal disorders1/4300/421
VomitingGastrointestinal disorders1/4300/421
Most frequent other events
Showing 10 of 29
Most frequent other events
EventDiosmectitePlacebo
Abdominal painGastrointestinal disorders9/4309/421
HeadacheNervous system disorders3/4307/421
Anorectal discomfortGastrointestinal disorders5/4303/421
ConstipationGastrointestinal disorders2/4303/421
NauseaGastrointestinal disorders1/4303/421
Spinal painMusculoskeletal and connective tissue disorders0/4302/421
Oropharyngeal painRespiratory, thoracic and mediastinal disorders1/4302/421
ProctalgiaGastrointestinal disorders2/4300/421
Back painMusculoskeletal and connective tissue disorders2/4300/421
DiarrhoeaGastrointestinal disorders0/4301/421

Baseline characteristics

The Intention-To-Treat (ITT) population included all randomised participants, analysed according to the arm to which they were randomised, except for those excluded from the analysis.

Age, Continuous
Age, Continuous(years)DiosmectitePlaceboTotal Title
Mean39.7 ± 14.538.6 ± 14.239.1 ± 14.4
Sex: Female, Male
Sex: Female, Male(Participants)DiosmectitePlaceboTotal Title
Female232241473
Male198182380
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)DiosmectitePlaceboTotal Title
Count of participants——0
08

Study locations

71 sites
  • Cabinet privé, Coopératives El MOSTAKBAL, BIRKHADEM
    Algiers, 16000, Algeria
  • CHU Beni Messous
    Algiers, 16000, Algeria
  • CHU Mustapha
    Algiers, 16000, Algeria
  • Polyclinique d'el Achour
    Algiers, 16000, Algeria
  • Polyclinique de Baba Hassen
    Algiers, 16000, Algeria
  • Cabinet privé, 29 avenue amara Youcef
    Blida, 09000, Algeria
  • EPH Blida
    Blida, 09000, Algeria
  • EPH EL Afroun
    Blida, 09000, Algeria
  • EPH Bologhine
    Bologhine, 16000, Algeria
  • Cabinet privé, cité des 408 lgmts Bt3
    Boumerdas, 35000, Algeria
  • CHU BEN BADIS Constantine
    Constantine, 25000, Algeria
  • Polyclinique de Dély Brahim
    Deli Ibrahim, 16000, Algeria
  • Polyclinique DRARIA
    Draria, 16000, Algeria
  • CHU Oran
    Oran, 31000, Algeria
  • Ordinace PL pro dospělé
    Praha 8, Karlín 186 00, Czechia
  • Ordinace PL pro dospělé
    Praha 4, Nusle 140 000, Czechia
  • Ordinace PL pro dospělé
    Praha 9, Vysočany 190 00, Czechia
  • OPL, spol. s r.o.
    Hrochův Týnec, 53862, Czechia
  • Ordinace PL pro dospělé
    Kladno, 27201, Czechia
  • Ordinace PL pro dospělé, Poliklinika přízemí, Nerudova
    Kralupy nad Vltavou, 278 01, Czechia
  • AK Medipraktik, s.r.o
    Orlová, 73514, Czechia
  • MUDr. Alena Břeňová - PL pro dospělé
    Pardubice, 53009, Czechia
  • Ordinace PL pro dospělé
    Praha 6, 2.patro, 160 00, Czechia
  • Ordinace PL pro dospělé
    Praha 6, 164 00, Czechia
  • Ordinace PL pro dospělé
    Praha 8, 182 00, Czechia
  • Ordinace Bělehradská s.r.o
    Praha, 12000, Czechia
  • Praktický lékař Radotín, s.r.o.
    Radotín, 15300, Czechia
  • Ordinace PL pro dospělé
    Vrchlabi, 54301, Czechia
  • Ordinace PL pro dospělé
    Čáslav, 286 01, Czechia
  • Clinical Research Center
    Alexandria, Egypt
  • Ain Shams University Hospitals
    Cairo, Egypt
  • Air Force Specialized Hospital
    Cairo, Egypt
  • Al Hussein University Hospital
    Cairo, Egypt
  • Badr University Hospital
    Cairo, Egypt
  • Cairo University
    Cairo, Egypt
  • Tanta University
    Tanta, Egypt
  • Hammoud Hospital University Medical Center
    Sidon, Lebanon
  • Komisji Edukacji Narodowej 3B lok. 1
    Białystok, 15-687, Poland
  • Cermed
    Białystok, 15270, Poland
  • KLIMED
    Bychawa, 23100, Poland
  • Indywidualna Specjalistyczna Praktyka Lekarska Roman Spyra
    Katowice, 40-018, Poland
  • MEKMED S.C. Przychodnia Lekarska NZOZ
    Katowice, 40-709, Poland
  • Lekarska Spółka Partnerska Familia T S A Gugała
    Kozienice, 26900, Poland
  • Praktyka Lekarzy Rodzinnych NZOZ
    Kraków, 30-664, Poland
  • Niepubliczny Zakład Opieki Zdrowotnej Ugorek sp. z o.o.
    Kraków, 31455, Poland
  • Niepubliczny Zakład Opieki Zdrowotnej Centrum Zdrowia i Profilaktyki "Dąbie" spółka z o.o.
    Kraków, 31567, Poland
  • Niepubliczny Zakład Opieki Zdrowotnej Praktyka Lekarza Rodzinnego "Eskulap" spółka z o.o.
    Lublin, 20-044, Poland
  • NZOZ Primed
    Malbork, 82-200, Poland
  • Solumed Research Site
    Poznań, 60529, Poland
  • Centrum Medyczne Pratia S.A
    Warsaw, 01868, Poland
  • PrzychodniaLekarska ORLIK Sp. z o.o
    Warszawa, 04-041, Poland
  • KLIMED
    Łomża, 18404, Poland
  • CSB Zouhour
    Ben Arous, 41200, Tunisia
  • Hôpital Régional de Ben Arous
    Ben Arous, Tunisia
  • Centre intermédiaire de Santé de Base
    La Marsa, 2078, Tunisia
  • Hôpital des Forces de Sécurité Intérieure
    La Marsa, 2078, Tunisia
  • CSB Hedi Chaker
    Sousse, 4000, Tunisia
  • Hôpital Universitaire Salhoul
    Sousse, 4011, Tunisia
  • CSB Akouda
    Sousse, 4022, Tunisia
  • CSB Sidi Bou Ali
    Sousse, 4022, Tunisia
  • CSB Zouhour
    Sousse, 4031, Tunisia
  • CSB Nager
    Sousse, 4041, Tunisia
  • CSB Riadh
    Sousse, 4041, Tunisia
  • CSB Oued Blibène
    Sousse, 4051, Tunisia
  • CSB Kalaa Kébira
    Sousse, 4060, Tunisia
  • CSB Zaouia
    Sousse, 4081, Tunisia
  • Centre de santé de base Bab Laasal
    Tunis, 1006, Tunisia
  • Hopital Militaire Principal d'instructions de Tunis
    Tunis, 1008, Tunisia
  • Centre de santé de base Ras Tabia
    Tunis, 2000, Tunisia
  • Centre de santé de base Ksar Said
    Tunis, 2009, Tunisia
  • Centre de santé de base Ibn Khaldoun
    Tunis, 2062, Tunisia
09

References and documents

Study documents

  • Study protocol · Jan 7, 2019
  • Statistical analysis plan · Jul 15, 2019

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02704091
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Mar 9, 2016
Start date
Mar 17, 2016
Primary completion
Apr 8, 2019
Completion
Apr 8, 2019
Results posted
Apr 24, 2020
Last update
Nov 5, 2020

Study contacts

Ipsen Medical Director
study director · Ipsen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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Discussion

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