Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Gastroenterology
Disease Category: Gastroesophageal Reflux Disease (GERD)

Trial Information

DO YOU HAVE PERSISTENT HEARTBURN (AT LEAST 2 DAYS A WEEK)?

It's possible that your symptoms are due to gastroesophageal reflux disease, or GERD. We are seeking volunteers 18 to 65 years old and in general good health who have been experiencing GERD symptoms (such as acid regurgitation, indigestion, or heartburn) for at least 2 days per week during the past month, and who have had heartburn or other GERD symptoms for at least the past 3 months. Qualified research study volunteers will be evaluated for the presence of erosions in the esophagus.

The purpose of this study is to evaluate whether or not an extended release investigational medication for the treatment of gastroesophageal reflux disease (GERD) is superior to a comparator drug (already on the market to treat GERD) in the healing of erosive esophagitis 4 weeks after initiation of treatment among study subjects with erosive gastroesophageal reflux disease (erosive GERD).

• Male or female adults 18 to 75 years of age
• Study duration: Study participants will be in the study for up to 14 weeks, or if healed at Week 4, then the duration of the study will be up to 10 weeks.
• Study treatment: Once daily extended release study drug (in capsule form) or a once daily oral dose of the comparator drug. Study treatment will last for 4 to 8 weeks.
• Study procedures: There will be an endoscopy at Visit 2 and four weeks later at Visit 4 to visualize the esophagus. If necessary, there will be another endoscopy at Visit 5 (four weeks after Visit 4).
• There is no charge for participation (study procedures, study medication, and study visits are no-cost).
• Compensation will be provided to participants to help cover study-related time and/or travel. Total possible compensation is $300; $25 for Visits 1, 3 & 6; $75 for Visits 2, 4 & 5. Note: There is no compensation for a pre-study visit.
• Principal Investigator: John Goff, M.D. of Rocky Mountain Gastroenterology Associates, P.C.

Patient Inclusion Criteria
Partial List

• History of GERD symptoms for at least 3 months (such as acid regurgitation, indigestion, or heartburn), with these symptoms occurring at least 2 days per week for the past month.
• Females of childbearing potential (this includes women who are not postmenopausal and/or who have not undergone surgical sterilization) must use a medically acceptable form of birth control during the entire study and for at least one month after the last dose of study drug.

Patient Exclusion Criteria Partial List

• Study participants must not require daily use of nonsteroidal anti-inflammatory medication (such as Advil, Aleve, Naproxen, etc.).
• Study participants may not have a history of a drastic weight loss during the past 2 months (a loss of more than 10% of total weight).
• Study participants may not have a history of esophageal strictures, Barrett¡¦s esophagus, inflammatory bowel disease, gastric cancer, unstable diabetes, or esophageal, gastric or duodenal surgery (except for the simple oversew of an ulcer).
• Females who are pregnant or lactating may not participate.
• Study participants must not experience difficulty swallowing pills.

Mary Reid, Jodi Frazier, Cheri Casey, Study Coordinators
Western States Clinical Research, Inc.
9201 W. 44th Avenue
Wheat Ridge, CO 80033
Phone: 303-940-0909
EMail: research@wscrinc.com

View Google Map

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.