Phase 3
N=190
Canadian Active & Maintenance Modified Pentasa Study
Active Ulcerative Colitis · Remission of Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT00603733 ↗Enrolled (actual)
190
Serious AEs
3.1%
Results posted
Apr 2016
Primary outcome: Primary: Active Phase: Proportion of Active Subjects Achieving Overall Improvement — 64.1; 69.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 5-ASA (5-Aminosalicylate) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Active Phase: Proportion of Active Subjects Achieving Overall Improvement |
64.1; 69.2 | — |
| PRIMARY Maintenance Phase: Proportion of Subjects Experiencing Relapse |
24.6; 11.8 | — |
| SECONDARY Frequency of Adverse Events |
52.4; 45.1 | — |
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 (UC) and also in maintenance of quiescent disease.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00603733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.