search
Back to results

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
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Duodenal Polyposis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 13, 2009
Last Updated
July 3, 2011
Sponsor
Oslo University Hospital
search

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

We'll reach out to this number within 24 hrs