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Coxib-inhibition of Duodenal Polyp Growth in FAP

This study has been terminated.
(Drug withdrawal)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00844727
First Posted: February 16, 2009
Last Update Posted: July 6, 2011
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.
Information provided by:
Oslo University Hospital
  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
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
Placebo
Drug: placebo
placebo pills

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • FAP patient with previous colectomy and confirmed polyposis

Exclusion Criteria:

  • Pregnancy
  • Malignancy
  • NSAID hypersensitivity
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00844727


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

ClinicalTrials.gov Identifier: NCT00844727     History of Changes
Other Study ID Numbers: RH01/01
First Submitted: February 13, 2009
First Posted: February 16, 2009
Last Update Posted: July 6, 2011
Last Verified: February 2009

Additional relevant MeSH terms:
Rofecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents