NCT00844727

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
Last Updated

July 6, 2011

Status Verified

February 1, 2009

Enrollment Period

7 months

First QC Date

February 13, 2009

Last Update Submit

July 3, 2011

Conditions

Duodenal Polyposis

Study Arms (2)

1

ACTIVE COMPARATOR

Rofexocib 25 mg OD, 1 year treatment

Drug: Rofecoxib

2

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

RofecoxibDRUG
1
placeboDRUG

placebo pills

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • FAP patient with previous colectomy and confirmed polyposis

You may not qualify if:

  • Pregnancy
  • Malignancy
  • NSAID hypersensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Medicine, Rikshospitalet

Oslo, Oslo County, 0027, Norway

Location

MeSH Terms

Interventions

rofecoxib

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 16, 2009

Study Start

September 1, 2003

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

July 6, 2011

Record last verified: 2009-02

Locations

NO(1)