MK0782 + Low-Dose Aspirin 7-Day Erosion Endoscopy Study - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00543868

Purpose

This study will determine how if MK0782 is safe and tolerable and to determine how often and the severity of stomach and small intestine ulcers develop following administration of MK0782 plus enteric coated aspirin, rofecoxib 25mg plus enteric coated aspirin, naproxen 500 mg puls enteric coated asprin vs placebo.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Condition	Intervention	Phase
Stomach Ulcer Duodenal Ulcer	Drug: MK0782	Phase II

Drug Information available for: Acetylsalicylic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Merck:

Study Start Date:	July 2004
Study Completion Date:	October 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male or non pregnant female
18 years of age or older (age at consent)
Able to abstain from alcohol, tobacco, spicy foods, limit coffee
Able to avoid strenuous activity
Able to read and fill out a study diary

Exclusion Criteria:

You have participated in an investigational drug study within 4 weeks of entering this study
Your weight is not within a specific range for the study
You have a history of GI problems like a gastric ulcer
You have had gastric or intestinal surgery
You have had abdominal or chest surgery
You are currently abusing drugs or alcohol or have a history of abuse
You have a history of psychiatric disorders
You are a smoker or have smoked during the last year

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543868

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Study ID Numbers:	2007_637
Study First Received:	October 5, 2007
Last Updated:	October 12, 2007
ClinicalTrials.gov Identifier:	NCT00543868
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Stomach Ulcer
Stomach Diseases
Digestive System Diseases
Aspirin
Gastrointestinal Diseases

Ulcer
Intestinal Diseases
Duodenal Diseases
Peptic Ulcer
Duodenal Ulcer

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009