A Study of Rofecoxib in Familial Adenomatous Polyposis (F... | NCT00140894

Studies
A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) (0966-205)(TERMINATED)

NCT00140894

Sponsor

Merck Sharp & Dohme LLC

Status

Terminated

Last Update Posted

Sep 20, 2019Actual

Enrollment

Phase

Phase 4

Conditions

Adenomatous Polyposis Coli

Interventions

MK0966; rofecoxib / Duration of Treatment: 24 weeks
Comparator: placebo / Duration of Treatment: 24 weeks

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2005_052

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 6, 2002Actual

Primary Completion Date

Not provided

Completion Date

Oct 11, 2004Actual

First Submitted Date

Aug 30, 2005

First Submission Date that Met QC Criteria

Aug 30, 2005

First Posted Date

Sep 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2019

Last Update Posted Date

Sep 20, 2019Actual

Description Module

Brief Summary

A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number and average size of rectal polyps
Safety and tolerability

Secondary Outcomes

Measure	Description	Time Frame
Number and average size of duodenal polyps
Proportions of patients with improved overall colon rating

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females at least 18 years of age with familial adenomatous polyposis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

http://engagezone.msd.com/ds_documentation.php

Condition Browse Module

MeSH Terms

ID	Term
D011125	Adenomatous Polyposis Coli
D010003	Osteoarthritis
D000072716	Cancer Pain

Ancestor Terms

ID	Term
D018256	Adenomatous Polyps
D000236	Adenoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C116926	rofecoxib
D000081206	Duration of Therapy

Ancestor Terms

ID	Term
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
MK0966; rofecoxib / Duration of Treatment: 24 weeks	Drug
Comparator: placebo / Duration of Treatment: 24 weeks	Drug