An interventional study of Supplement and Placebo in Gastroesophageal Reflux Disease (GERD), Heartburn and Dyspepsia, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment
Among 420 studies in Gastroesophageal Reflux with a site in United States — 54 open to participants now, 69 under way, 2 of them phase 3. Gastroesophageal Reflux · United States.
Among the 420 studies in Gastroesophageal Reflux with a site in United States, this one is the 221st largest by enrollment of the 301 interventional ones that give a count, is one of 14 that started in 2013, is one of 155 with no phase, and was the 233rd registered.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
Browse Gastroesophageal Reflux studies →54 of the 420 studies in Gastroesophageal Reflux with a site in United States are open now. Recruiting first, the newest first:
Phathom Pharmaceuticals, Inc. · Sites in United States
Ages 18+
Johns Hopkins University · Sites in United States
Ages 21+
Medical College of Wisconsin · Sites in United States
Ages 18+ · Healthy volunteers
Abbott Medical Devices · Sites in United States
Ages 18+
Children's Hospital of Philadelphia · Sites in United States
Ages 1 mo–12 mo
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 132 Gastroesophageal Reflux studies recruiting now, 56 (42%) set no upper age limit and 53 (40%) stop at 75 or younger; 22 take children under 18; 20 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
420 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 31 · Phase 2 45 · Phase 3 47 · Phase 4 34
First in 1999; this study’s year is marked. 14 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 24 is below the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Median enrollment 60 across the 301 interventional studies, 90 across the 116 observational. Of the 304 that completed or were terminated, 116 (38%) have results posted.
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128 of 420 have an industry lead sponsor. The 10 most frequent:
Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 79 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
Beth Israel Deaconess Medical Center has 2 studies filed under Gastroesophageal Reflux — fewer than ten, so there is no comparison to draw.
26 of the studies in Gastroesophageal Reflux with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07752407Phase 3Phathom Pharmaceuticals, Inc.A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks | 2027-10-20 |
| NCT01696734Phase 3M.D. Anderson Cancer CenterDomperidone in Treating Patients With Gastrointestinal Disorders | 2027-10-31 |
| NCT04506593Indiana UniversityIndiana University Gastrointestinal Motility Diagnosis Registry | 2026-11 |
| NCT05697393Medical College of WisconsinExternal UES Band (Shaker Pressure Band) and GERD | 2026-11-30 |
| NCT03705416Johns Hopkins UniversityLong Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy | 2026-12 |
Add all 26 to your calendar (.ics) → With an account.
Among the 420 studies in Gastroesophageal Reflux with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to investigate the effects of a widely available over the counter supplement marketed for heartburn symptoms on symptoms and health-related quality of life in patients with gastroesophageal reflux disease (GERD). This study is designed as a pilot trial to assess safety and feasibility and to provide preliminary estimates of effect sizes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Drug: Supplement · Behavioral: Expanded Interview
Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Drug: Placebo · Behavioral: Standard Interview
Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Drug: Supplement · Behavioral: Standard Interview
Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Drug: Placebo · Behavioral: Expanded Interview
Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Lactose tablets
Safety - Number of Participants Experiencing a Serious Adverse Event
Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.
Time frame: 2 week follow-up
Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity
Average daily GERD symptom severity during the last 7 days of the study was compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day was based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms. The number of subjects with a 50% or greater decrease in GERD symptom severity from baseline to end of study in each group was calculated.
Time frame: Second week of the trial compared to pre-trial baseline
GERD Health-Related Quality of Life at Follow-up
The GERD Health-Related Quality of Life (GERD-HRQL) scale is a validated instrument assessing GERD-specific health-related quality of life using 10 questions, each on a 0-5 point scale. Scale range is 0-50 with higher numbers signifying worse quality of life.
Time frame: Two weeks
| Milestone | Supplement + Expanded Interview | Placebo + Standard Interview | Supplement + Standard Interview | Placebo + Expanded Interview |
|---|---|---|---|---|
| Started | 6 | 6 | 6 | 6 |
| Completed | 6 | 6 | 6 | 6 |
| Not completed | 0 | 0 | 0 | 0 |
Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.
| participants | Placebo + Standard Interview | Supplement + Standard Interview | Placebo + Expanded Interview | Supplement + Expanded Interview |
|---|---|---|---|---|
| Safety - Number of Participants Experiencing a Serious Adverse Event | 0 | 0 | 0 | 0 |
Average daily GERD symptom severity during the last 7 days of the study was compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day was based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms. The number of subjects with a 50% or greater decrease in GERD symptom severity from baseline to end of study in each group was calculated.
| participants | Placebo + Standard Interview | Supplement + Standard Interview | Placebo + Expanded Interview | Supplement + Expanded Interview |
|---|---|---|---|---|
| Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity | 2 | 0 | 5 | 4 |
The GERD Health-Related Quality of Life (GERD-HRQL) scale is a validated instrument assessing GERD-specific health-related quality of life using 10 questions, each on a 0-5 point scale. Scale range is 0-50 with higher numbers signifying worse quality of life.
| units on a scale | Placebo + Standard Interview | Supplement + Standard Interview | Placebo + Expanded Interview | Supplement + Expanded Interview |
|---|---|---|---|---|
| GERD Health-Related Quality of Life at Follow-up | 18.2 ± 4.5 | 26.3 ± 7.8 | 17.7 ± 3.4 | 18.3 ± 4.9 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo + Standard Interview | — | 0/6 (0%) | 4/6 (66.7%) |
| Supplement + Standard Interview | — | 0/6 (0%) | 1/6 (16.7%) |
| Placebo + Expanded Interview | — | 0/6 (0%) | 4/6 (66.7%) |
| Supplement + Expanded Interview | — | 0/6 (0%) | 4/6 (66.7%) |
| Event | Placebo + Standard Interview | Supplement + Standard Interview | Placebo + Expanded Interview | Supplement + Expanded Interview |
|---|---|---|---|---|
| Cramping or abdominal discomfortGastrointestinal disorders | 2/6 | 0/6 | 1/6 | 1/6 |
| Diarrhea or loose stoolsGastrointestinal disorders | 2/6 | 0/6 | 1/6 | 0/6 |
| HeartburnGastrointestinal disorders | 1/6 | 1/6 | 2/6 | 1/6 |
| HeadacheNervous system disorders | 2/6 | 0/6 | 0/6 | 2/6 |
| ConstipationGastrointestinal disorders | 0/6 | 0/6 | 1/6 | 1/6 |
| FlatulenceGastrointestinal disorders | 1/6 | 0/6 | 1/6 | 0/6 |
| BurpingGastrointestinal disorders | 0/6 | 0/6 | 1/6 | 1/6 |
| Cough or congestionRespiratory, thoracic and mediastinal disorders | 1/6 | 0/6 | 0/6 | 0/6 |
| Nausea and/or vomitingGastrointestinal disorders | 1/6 | 1/6 | 1/6 | 0/6 |
| Throat or mouth discomfortRespiratory, thoracic and mediastinal disorders | 0/6 | 0/6 | 0/6 | 1/6 |
| Age, Categorical(Participants) | Placebo + Standard Interview | Supplement + Standard Interview | Placebo + Expanded Interview | Supplement + Expanded Interview | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 4 | 5 | 5 | 17 |
| >=65 years | 3 | 2 | 1 | 1 | 7 |
| Age, Continuous(years) | Placebo + Standard Interview | Supplement + Standard Interview | Placebo + Expanded Interview | Supplement + Expanded Interview | Total |
|---|---|---|---|---|---|
| Mean | 60 ± 14 | 64 ± 6.3 | 54 ± 9.9 | 53 ± 12 | 58 ± 11 |
| Sex: Female, Male(Participants) | Placebo + Standard Interview | Supplement + Standard Interview | Placebo + Expanded Interview | Supplement + Expanded Interview | Total |
|---|---|---|---|---|---|
| Female | 4 | 4 | 4 | 4 | 16 |
| Male | 2 | 2 | 2 | 2 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Placebo + Standard Interview | Supplement + Standard Interview | Placebo + Expanded Interview | Supplement + Expanded Interview | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 6 | 6 | 6 | 5 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Placebo + Standard Interview | Supplement + Standard Interview | Placebo + Expanded Interview | Supplement + Expanded Interview | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 1 | 2 | 7 |
| White | 4 | 3 | 3 | 3 | 13 |
| More than one race | 0 | 0 | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| GERD symptom severity(scores on a scale) | Placebo + Standard Interview | Supplement + Standard Interview | Placebo + Expanded Interview | Supplement + Expanded Interview | Total |
|---|---|---|---|---|---|
| Mean | 4.2 ± 2.1 | 5.6 ± 2.6 | 3.6 ± 2.2 | 3.8 ± 2.3 | 4.3 ± 2.3 |
The record gives a start of Jun 2013, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2017, 2 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center →