Canadian Active & Maintenance Modified Pentasa Study (CAMMP)

This study has been completed.

Sponsor:

Information provided by:

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00603733

First received: January 16, 2008

Last updated: June 29, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 16, 2008

Last Updated Date

June 29, 2011

Start Date ^ICMJE

October 2007

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary efficacy endpoint is the proportion of active subjects at Week 8 to achieve improvement from baseline and the proportion of maintenance subjects who experience relapse before Week 24. [ Time Frame: 8 weeks for Active Phase & 24 weeks for maintenance phase ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The primary efficacy endpoint is the proportion of active study subjects at Week 8 in the active disease treatment phase in each treatment group to achieve an overall improvement from baseline. [ Time Frame: 8 weeks for Active Phase & 24 weeks for maintenance phase ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00603733 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Secondary Endpoints Safety will be compared between the two 5-ASA groups in both the active and the maintenance phase of the study. [ Time Frame: 8 weeks for active & 24 weeks for maintenance phase. ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Canadian Active & Maintenance Modified Pentasa Study

Official Title ^ICMJE

A Safety & Efficacy Study of Pentasa for Mild to Moderate Ulcerative Colitis Patients

Brief Summary

The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative Colitis and also in maintenance of quiescent disease.

Detailed Description

A multi-centre, randomized, double-blind, non-inferiority trial comparing the efficacy and safety of a new modified oral extended release Pentasa® (mesalamine) 500 mg tablet to the currently marketed Pentasa® (mesalamine) 500 mg tablet in subjects with active mild to moderate ulcerative colitis treated with 4 g/day for 8 weeks and in maintenance of remission of ulcerative colitis in subjects treated with 2 g/day for 24 weeks. The study involves male or non-pregnant female subjects aged 18 to 75 years.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Condition ^ICMJE

Active Ulcerative Colitis
Remission of Ulcerative Colitis

Intervention ^ICMJE

Drug: 5-ASA (5-Aminosalicylate)

Pentasa (mesalamine) 500mg tablet

Study Arm (s)

Active Comparator: 1
Intervention: Drug: 5-ASA (5-Aminosalicylate)
Active Comparator: 2
Intervention: Drug: 5-ASA (5-Aminosalicylate)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

343

Completion Date

June 2011

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Newly diagnosed or recurrent Ulcerative Colitis patients who are flaring or in remission.
Screening tests to rule out any abnormalities in stool, heart or kidney.
Male or non-pregnant females between 18 to 75 years.

Exclusion Criteria:

Use of 5-ASA products at a dose >2.5g/day within 7 days prior to entry.
Proctitis, short bowel syndrome, prior bowel surgery, severe UC, other forms of IBD
Infectious diseases, parasites, bacterial pathogens
Allergy to aspirin or salicylate
Liver or kidney abnormalities
Alcohol or drug abuse
Pregnancy
Cancer
Bleeding disorders, ulcers, autoimmune diseases
Mental disorders
Participation in clinical trial in last 30 days
Inability to fill in diary cards / comply with protocol requirements

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00603733

Other Study ID Numbers ^ICMJE

FE999907 (PENTASA), CAMMP CLN 35.3.11

Has Data Monitoring Committee

Responsible Party

Clincial Development Support, Ferring Pharmaceuticals

Study Sponsor ^ICMJE

Ferring Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

Information Provided By

Ferring Pharmaceuticals

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top