Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tillotts Pharma AG
ClinicalTrials.gov Identifier:
NCT01059344
First received: January 28, 2010
Last updated: September 16, 2013
Last verified: April 2013

January 28, 2010
September 16, 2013
November 2009
July 2011   (final data collection date for primary outcome measure)
The primary objective of the study is to determine the efficacy of Asacol™ 4.8 g/day (800 mg tablets) to induce clinical and endoscopic remission after 6 weeks of treatment compared to placebo in subjects with active ulcerative colitis (UC). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01059344 on ClinicalTrials.gov Archive Site
▪ the proportion of subjects achieving clinical and endoscopic remission at both Week 6 and Week 10 ▪ the proportion of subjects achieving clinical remission at Week 6 ▪ the proportion of subjects achieving clinical improvement at Week 6 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis
A Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis

Asacol™ 4.8 g/day (800 mg tablets) is statistically significant more effective to induce clinical and endoscopic remission after 6 weeks of treatment compared to placebo in subjects with active ulcerative colitis (UC).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ulcerative Colitis
Drug: Mesalamin
4.8g/day, 800 mg tablets
Other Name: Asacol
  • Experimental: Mesalamin
    Intervention: Drug: Mesalamin
  • Placebo Comparator: Placebo
    Intervention: Drug: Mesalamin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
281
August 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

(1) Male or non-pregnant, non-lactating females, 18 years of age or older. (2) Documented diagnosis of UC with disease extending at least 15 cm from the anal verge.

(3) Active UC defined by:

(a) modified UC-DAI score of 4-10 with (b) sigmoidoscopy component score ≥ 2 and (c) rectal bleeding component score ≥ 1 (4) Ability of subject to participate fully in all aspects of this clinical trial.

(5) Written informed consent must be obtained and documented.

Exclusion Criteria:

  1. Severe UC defined by the following criteria:

    ³6 bloody stools daily with one or more of the following:

    1. oral temperature > 37.8°C or > 100.0°F
    2. pulse > 90/min
    3. hemoglobin < 10 g/dL
  2. Previously failed treatment with a mesalazine dose of > 2.0 g/day.
  3. Current relapse lasting > 6 weeks in the opinion of the investigator.
  4. Treatment with 5-ASA at a dose of >2.0g/day within 1 week prior to randomisation
  5. Treatment with systemic or rectal steroids within 4 weeks prior to randomization.
  6. Treatment with immunosuppressants within 6 weeks prior to randomization.
  7. Treatment with infliximab or other biologics within 3 months prior to randomization.
  8. Treatment with systemic antibiotics for UC within 7 days prior to randomization.
  9. Treatment with probiotics within 7 days prior to randomization.
  10. Treatment with anti-diarrheals within 7 days prior to randomization.
  11. Treatment with nicotine patch within 7 days prior to randomization.
  12. Received any investigational drug within 30 days prior to randomization.
  13. History of colectomy or partial colectomy.
  14. History of definite dysplasia in colonic biopsies.
  15. Crohn's disease.
  16. Known bleeding disorders.
  17. Immediate or significant risk of toxic megacolon.
  18. Hypersensitivity to salicylates, aspirin, sulfasalazine or 5-ASA.
  19. Serum creatinine > 1.5 times the upper limit of the normal range.
  20. AST, ALT, total bilirubin or alkaline phosphatase > 2 times the upper limit of the normal range.
  21. Serious underlying disease other than UC which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study.
  22. History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
  23. Stools positive for clostridium difficile.
  24. Pregnant or lactating women.
  25. Prior enrolment in the current study and had received study treatment.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Turkey,   Belarus,   Ukraine,   India
 
NCT01059344
TP0203
No
Tillotts Pharma AG
Tillotts Pharma AG
Not Provided
Study Chair: Brian Feagan, MD Robarts Clinical Trials
Tillotts Pharma AG
April 2013

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