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Coxib-inhibition of Duodenal Polyp Growth in FAP

This study has been terminated.
(Drug withdrawal)
Information provided by:
Oslo University Hospital Identifier:
First received: February 13, 2009
Last updated: July 3, 2011
Last verified: February 2009
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:

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
Drug: placebo
placebo pills


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • FAP patient with previous colectomy and confirmed polyposis

Exclusion Criteria:

  • Pregnancy
  • Malignancy
  • NSAID hypersensitivity
  Contacts and Locations
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Please refer to this study by its identifier: NCT00844727

Dept of Medicine, Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
  More Information Identifier: NCT00844727     History of Changes
Other Study ID Numbers: RH01/01
Study First Received: February 13, 2009
Last Updated: July 3, 2011

Additional relevant MeSH terms:
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on August 16, 2017