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Canadian Active & Maintenance Modified Pentasa Study (CAMMP)

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Ferring

Status and phase

Completed
Phase 3

Conditions

Remission of Ulcerative Colitis
Active Ulcerative Colitis

Treatments

Drug: 5-ASA (5-Aminosalicylate)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00603733
CLN 35.3.11

Details and patient eligibility

About

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 (UC) and also in maintenance of quiescent disease.

Full 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.

Subjects were randomised on entry into the trial, and if they were in remission at the end of the 8-week Active Phase or the 4-week Run-in Phase, they were eligible for enrolment into the 24-week Maintenance Phase, remaining on the original randomised treatment.

Enrollment

288 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Active phase:

  • Newly diagnosed or recurrent, mild to moderate Ulcerative Colitis patients.
  • Extent of colonic involvement confirmed within the past 36 months
  • UCDAI score of at least 3 but not greater than 8 and a score of at least 1 for endoscopy
  • Screening tests to rule out any abnormalities in stool, heart or kidney.
  • Male or non-pregnant females between 18 to 75 years.
  • Women of childbearing potential to use efficacious contraception as judged by the investigator.
  • Written informed consent given.

Inclusion Criteria for Maintenance phase:

  • Newly recruited subjects with documented mild to moderate UC entering the Run-in Phase: in clinical remission for at least 1 month and for a maximum of 3 years, and receiving 5-ASA 1.4 to 2.5 g/day for maintenance of quiescent disease
  • Subjects from Active Phase: meeting remission criteria after the 8-week active period
  • Extent of colonic involvement confirmed within the past 36 months by colonoscopy
  • In complete remission at entry into the Maintenance Phase, defined as i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings; and iv) a Physician's Global Assessment (PGA) score of 0 or 1
  • Screening tests to rule out any abnormalities in stool, heart or kidney.

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 Inflammatory Bowel Disease
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

288 participants in 2 patient groups

Pentasa® modified extended release
Experimental group
Description:
5-ASA (5-Aminosalicylate)
Treatment:
Drug: 5-ASA (5-Aminosalicylate)
Drug: 5-ASA (5-Aminosalicylate)
Pentasa®
Active Comparator group
Description:
5-ASA (5-Aminosalicylate)
Treatment:
Drug: 5-ASA (5-Aminosalicylate)
Drug: 5-ASA (5-Aminosalicylate)

Trial contacts and locations

27

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Data sourced from clinicaltrials.gov

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