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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00140894
Other study ID # 0966-205
Secondary ID 2005_052
Status Terminated
Phase Phase 4
First received
Last updated
Start date August 6, 2002
Est. completion date October 11, 2004

Study information

Verified date September 2019
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.


Recruitment information / eligibility

Status Terminated
Enrollment 62
Est. completion date October 11, 2004
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Males or females at least 18 years of age with familial adenomatous polyposis.

Study Design


Intervention

Drug:
MK0966; rofecoxib / Duration of Treatment: 24 weeks

Comparator: placebo / Duration of Treatment: 24 weeks


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Number and average size of rectal polyps
Primary Safety and tolerability
Secondary Number and average size of duodenal polyps
Secondary Proportions of patients with improved overall colon rating
See also
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Completed NCT05014360 - A Study of JNJ-64251330 in Participants With Familial Adenomatous Polyposis Phase 1
Completed NCT01604564 - Registry With Information About Colitis Ulcerosa and Familial Adenomatous Polyposis Patients
Recruiting NCT05919264 - FOG-001 in Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT02113202 - Molecular Fluorescence Endoscopy in Patients With Familial Adenomatous Polyposis, Using Bevacizumab-IRDye800CW Phase 1
Withdrawn NCT03027401 - Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics
Recruiting NCT06435533 - Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis N/A
Active, not recruiting NCT01187901 - A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients Phase 2
Recruiting NCT00319007 - Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis Phase 2
No longer available NCT04948398 - Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis