Coxib-inhibition of Duodenal Polyp Growth in FAP
Primary Purpose
Duodenal Polyposis
Status
Terminated
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Rofecoxib
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Duodenal Polyposis
Eligibility Criteria
Inclusion Criteria:
- FAP patient with previous colectomy and confirmed polyposis
Exclusion Criteria:
- Pregnancy
- Malignancy
- NSAID hypersensitivity
Sites / Locations
- Dept of Medicine, Rikshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Rofexocib 25 mg OD, 1 year treatment
Placebo
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00844727
First Posted
February 13, 2009
Last Updated
July 3, 2011
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00844727
Brief Title
Coxib-inhibition of Duodenal Polyp Growth in FAP
Official Title
Coxib-inhibition of Duodenal Polyp Growth in Familial Adenomatous Polyposis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Terminated
Why Stopped
Drug withdrawal
Study Start Date
September 2003 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duodenal Polyposis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Rofexocib 25 mg OD, 1 year treatment
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Rofecoxib
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo pills
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
FAP patient with previous colectomy and confirmed polyposis
Exclusion Criteria:
Pregnancy
Malignancy
NSAID hypersensitivity
Facility Information:
Facility Name
Dept of Medicine, Rikshospitalet
City
Oslo
ZIP/Postal Code
0027
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Coxib-inhibition of Duodenal Polyp Growth in FAP
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