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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: June 27, 2017
Last verified: June 2017
January 28, 2010
June 27, 2017
November 2009
July 2011   (Final data collection date for primary outcome measure)
To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). [ Time Frame: 6 weeks ]
Clinical remission defined as stool frequency score of 0, rectal bleeding score of 0, no urgency
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 ]
Complete list of historical versions of study NCT01059344 on ClinicalTrials.gov Archive Site
  • Clinical Remission [ Time Frame: 10 weeks ]
    Clinical remission defined as a score of 0 for stool frequency, 0 for rectal bleeding and no urgency
  • Endoscopic Remission [ Time Frame: 6 weeks ]
    Endoscopic remission is defined as a sigmoidoscopy score of 1 or less
  • Endoscopic Remission [ Time Frame: 10 weeks ]
    Endoscopic remission is defined as a sigmoidoscopy score of 1 or less
  • Improvement [ Time Frame: 6 weeks ]
    Improvement is defined as a reduction of at least 3 points from baseline in the modified UC-DAI score. (minumum 3, maximum 7, higher absolute UC-DAI scores indicate more severe disease)
  • Improvement [ Time Frame: 10 weeks ]
    Improvement is defined as a reduction of at least 3 points from baseline in the modified UC-DAI score. (minumum 3, maximum 7, higher absolute UC-DAI scores indicate more severe disease)
▪ 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 ]
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
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).
The 800 mg Asacol™ tablets from Tillotts Pharma AG are being marketed in over 30 countries, mainly in Europe and Asia. Approved dosages for the treatment of active UC are between 2.4 and 4.8 g/day in analogy to the approved 400 mg dosage form. The present trial is planned to generate efficacy data to support the safe use of a 4.8 g/day dose of the 800 mg dosage form in a well defined population of patients with mildly to moderately active UC. In keeping with the EMEA UC guideline the study will have a placebo-controlled 6 weeks induction treatment. After 6 weeks, treatment success will be evaluated using the modified UC disease activity index as primary efficacy measurement.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ulcerative Colitis
Drug: Mesalamin
4.8g/day, 800 mg tablets
Other Name: Asacol
  • Experimental: Mesalamin
    4.8g Mesalamin (800mg tablet)
    Intervention: Drug: Mesalamin
  • Placebo Comparator: Placebo
    4.8g Placebo to Mesalamin (800 mg tablet)
    Intervention: Drug: Mesalamin
Feagan BG, Sandborn WJ, D'Haens G, Pola S, McDonald JW, Rutgeerts P, Munkholm P, Mittmann U, King D, Wong CJ, Zou G, Donner A, Shackelton LM, Gilgen D, Nelson S, Vandervoort MK, Fahmy M, Loftus EV Jr, Panaccione R, Travis SP, Van Assche GA, Vermeire S, Levesque BG. The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis. Gastroenterology. 2013 Jul;145(1):149-157.e2. doi: 10.1053/j.gastro.2013.03.025. Epub 2013 Mar 22.

*   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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belarus,   India,   Turkey,   Ukraine
 
 
NCT01059344
TP0203
No
Not Provided
Plan to Share IPD: No
Tillotts Pharma AG
Tillotts Pharma AG
Not Provided
Study Chair: Brian Feagan, MD Robarts Clinical Trials Inc.
Tillotts Pharma AG
June 2017

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