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Coxib-inhibition of Duodenal Polyp Growth in FAP

This study has been terminated.
(Drug withdrawal)
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00844727
First received: February 13, 2009
Last updated: July 3, 2011
Last verified: February 2009
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Coxib-inhibition of Duodenal Polyp Growth in Familial Adenomatous Polyposis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

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
Active Comparator: 1
Rofexocib 25 mg OD, 1 year treatment
 Drug: Rofecoxib
Placebo Comparator: 2
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
Oslo University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00844727     History of Changes
Other Study ID Numbers: RH01/01
Study First Received: February 13, 2009
Last Updated: July 3, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Adenomatous Polyposis Coli
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Intestinal Polyposis
Genetic Diseases, Inborn
Rofecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013