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Coxib-inhibition of Duodenal Polyp Growth in FAP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00844727
Recruitment Status : Terminated (Drug withdrawal)
First Posted : February 16, 2009
Last Update Posted : July 6, 2011
Information provided by:
Oslo University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Duodenal Polyposis Drug: Rofecoxib Drug: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Coxib-inhibition of Duodenal Polyp Growth in Familial Adenomatous Polyposis
Study Start Date : September 2003
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

Arm Intervention/treatment
Active Comparator: 1
Rofexocib 25 mg OD, 1 year treatment
Drug: Rofecoxib
Placebo Comparator: 2
Drug: placebo
placebo pills

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00844727

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Dept of Medicine, Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital

Layout table for additonal information Identifier: NCT00844727     History of Changes
Other Study ID Numbers: RH01/01
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: February 2009

Additional relevant MeSH terms:
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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