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| ID | Type | Description | Link |
|---|---|---|---|
| IND 117358 | Other Identifier | FDA |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplement + Expanded Interview | Experimental | Supplement, 2 tablets sublingually 3 times a day for 2 weeks. |
|
| Placebo + Standard Interview | Placebo Comparator | Placebo, 2 tablets sublingually 3 times a day for 2 weeks. |
|
| Supplement + Standard Interview | Experimental | Supplement, 2 tablets sublingually 3 times a day for 2 weeks. |
|
| Placebo + Expanded Interview | Placebo Comparator | Placebo, 2 tablets sublingually 3 times a day for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplement | Drug | Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Dossett, MD, PhD, MPH | Beth Israel Deaconess Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26422466 | Result | Dossett ML, Mu L, Davis RB, Bell IR, Lembo AJ, Kaptchuk TJ, Yeh GY. Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial. PLoS One. 2015 Sep 30;10(9):e0136855. doi: 10.1371/journal.pone.0136855. eCollection 2015. |
| Label | URL |
|---|---|
| study manuscript | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supplement + Expanded Interview | Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Expanded Interview |
| FG001 | Placebo + Standard Interview | Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Standard Interview |
| FG002 | Supplement + Standard Interview | Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Standard Interview |
| FG003 | Placebo + Expanded Interview | Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Expanded Interview |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Standard Interview | Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Standard Interview |
| BG001 | Supplement + Standard Interview |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All enrolled study participants. | Posted | Number | participants | 2 week follow-up |
|
2 weeks
Data collected from subject symptom diaries.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo + Standard Interview | Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Standard Interview |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cramping or abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
Small, pilot study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle L. Dossett, MD, PhD, MPH | Massachusetts General Hospital | 617-643-6034 | mdossett@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo | Drug | Lactose tablets |
|
| Expanded Interview | Behavioral |
|
| Standard Interview | Behavioral |
|
| 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. | Two weeks |
Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Standard Interview
| BG002 | Placebo + Expanded Interview | Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Expanded Interview |
| BG003 | Supplement + Expanded Interview | Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Expanded Interview |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| GERD symptom severity | GERD symptom severity was calculated by averaging the severity of GERD symptoms over a 7 day period based on the sum of scores from daily symptom diaries 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 (range 0-12). | Mean | Standard Deviation | scores on a scale |
|
Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Standard Interview
| OG002 | Placebo + Expanded Interview | Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Expanded Interview |
| OG003 | Supplement + Expanded Interview | Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Expanded Interview |
|
|
| Secondary | 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. | All enrolled study participants. | Posted | Number | participants | Second week of the trial compared to pre-trial baseline |
|
|
|
|
| Secondary | 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. | All enrolled study participants. | Posted | Mean | Standard Deviation | units on a scale | Two weeks |
|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | Supplement + Standard Interview | Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Standard Interview | 0 | 6 | 1 | 6 |
| EG002 | Placebo + Expanded Interview | Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Expanded Interview | 0 | 6 | 4 | 6 |
| EG003 | Supplement + Expanded Interview | Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Expanded Interview | 0 | 6 | 4 | 6 |
|
| Diarrhea or loose stools | Gastrointestinal disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
|
| Heartburn | Gastrointestinal disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
|
| Burping | Gastrointestinal disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
|
| Headache | Nervous system disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
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| Cough or congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
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| Nausea and/or vomiting | Gastrointestinal disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
|
| Throat or mouth discomfort | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
|
| Sweating | General disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
|
| Fatigue | General disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
|
| Bright red blood per rectum | Gastrointestinal disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment | Subject-reported symptom on daily symptom diary, may not be a true adverse event. |
|
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| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
All 4 arms were combined to compare the Placebo groups to the Supplement groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity. |
| Regression, Logistic |
| 0.33 |
| 2-Sided |
| Superiority or Other |