Response to Supplement and Placebo in GERD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01915173
First received: July 30, 2013
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Gastroesophageal Reflux Disease (GERD)
Heartburn
Dyspepsia
Drug: Supplement
Drug: Placebo
Behavioral: Expanded Interview
Behavioral: Standard Interview

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Response to Supplement and Placebo in GERD

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Safety - number of major and minor adverse events [ Time Frame: 2 week follow-up ] [ Designated as safety issue: Yes ]
    No major adverse events (as defined by FDA criteria) attributed to the study intervention and no statistically significant increase in minor adverse events between the intervention and placebo arms.


Secondary Outcome Measures:
  • Percent of subjects with a 50% or greater decrease in heartburn symptom severity [ Time Frame: Second week of the trial compared to pre-trial baseline ] [ Designated as safety issue: No ]
    Based on daily symptom diary scores.

  • Percent improvement in disease-specific and overall quality of life [ Time Frame: Two weeks (baseline to follow-up) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supplement + Expanded Interview
Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Drug: Supplement
Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Behavioral: Expanded Interview
Placebo Comparator: Placebo + Standard Interview
Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Drug: Placebo
Lactose tablets
Behavioral: Standard Interview
Experimental: Supplement + Standard Interview
Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Drug: Supplement
Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Behavioral: Standard Interview
Placebo Comparator: Placebo + Expanded Interview
Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Drug: Placebo
Lactose tablets
Behavioral: Expanded Interview

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult humans age 18-80.
  • Fluency in written and spoken English.
  • Heartburn symptoms 3 or more days per week for the past month.

Exclusion Criteria:

  • Individuals taking a proton pump inhibitor (PPI) or H2 receptor blocker with a dose change within 2 weeks of the initial study visit.
  • Individuals with Crohns disease, systemic sclerosis, known active ulcer disease, gastric cancer, Barrett's esophagitis
  • Significant pain or difficulty with swallowing
  • Heavy alcohol use (defined by > 6 drinks/week for women and > 13 drinks/week for men)
  • Concurrent pregnancy
  • Dementia
  • Uncontrolled psychiatric disease
  • Individuals unable to complete a paper symptom diary for 6 of 7 days prior to their baseline visit
  • Subjects whose symptoms are predominantly dyspeptic more than heartburn or reflux
  • Subjects who have used homeopathy for GI symptoms or have received constitutional homeopathic treatment within the past 2 weeks
  • Subjects taking herbal products or other supplements for GERD or dyspepsia related symptoms (includes peppermint oil)
  • Subjects who have taken > 12 doses of NSAIDS within the prior 30 days (aspirin ≤ 325 mg daily is allowed)
  • Subjects with lactose intolerance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915173

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Study Director: Michelle Dossett, MD, PhD, MPH Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01915173     History of Changes
Other Study ID Numbers: 2012-P-000409, IND 117358
Study First Received: July 30, 2013
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
Gastroesophageal reflux disease (GERD)
Heartburn
Dyspepsia

Additional relevant MeSH terms:
Gastroesophageal Reflux
Dyspepsia
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014