Coxib-Inhibition of Duodenal Polyp Growth in FAP

This study has been terminated.

( Drug withdrawal )

First Received: February 13, 2009 No Changes Posted

Sponsored by:	Rikshospitalet HF
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00844727

Purpose

Preliminary data indicate a protective effect on the development of duodenal polyps by coxib treatment. The hypothesis of the present study is that normal therapy doses of rofecoxib for 1 year would stop or reverse the development of premalignant adenomatous lesions in the duodenal mucosa of FAP patients.

Condition	Intervention	Phase
Duodenal Polyposis	Drug: Rofecoxib Drug: placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment
Official Title:	Coxib-Inhibition of Duodenal Polyp Growth in Familial Adenomatous Polyposis

Resource links provided by NLM:

Genetics Home Reference related topics: familial adenomatous polyposis

Drug Information available for: Rofecoxib

U.S. FDA Resources

Further study details as provided by Rikshospitalet HF:

Enrollment:	38
Study Start Date:	September 2003
Study Completion Date:	April 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Rofexocib 25 mg OD, 1 year treatment	Drug: Rofecoxib
2: Placebo Comparator Placebo	Drug: placebo placebo pills

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

FAP patient with previous colectomy and confirmed polyposis

Exclusion Criteria:

Pregnancy
Malignancy
NSAID hypersensitivity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844727

Locations

Norway
Dept of Medicine, Rikshospitalet
Oslo, Norway, 0027

Sponsors and Collaborators

Rikshospitalet HF

More Information

No publications provided

Study ID Numbers:	RH01/01
Study First Received:	February 13, 2009
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00844727 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Study placed in the following topic categories:

Familial Polyposis
Digestive System Neoplasms
Adenomatous Polyposis Coli
Gastrointestinal Diseases
Familial Adenomatous Polyposis
Colonic Diseases
Polyps
Intestinal Diseases
Intestinal Neoplasms
Neoplastic Syndromes, Hereditary

Digestive System Diseases
Genetic Diseases, Inborn
Rofecoxib
Gastrointestinal Neoplasms
Adenoma
Colonic Neoplasms
Adenomatous Polyps
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Intestinal Polyposis
Neoplasms by Histologic Type
Digestive System Neoplasms
Gastrointestinal Diseases
Adenomatous Polyposis Coli
Colonic Diseases
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Digestive System Diseases

Neoplasms by Site
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Gastrointestinal Neoplasms
Adenoma
Colonic Neoplasms
Adenomatous Polyps
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 01, 2009