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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00543868
Other study ID # 0782-001
Secondary ID 2007_637
Status Completed
Phase Phase 2
First received October 5, 2007
Last updated June 10, 2015
Start date June 2004
Est. completion date August 2004

Study information

Verified date June 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 462
Est. completion date August 2004
Est. primary completion date August 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
MK0782


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.
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