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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01059344
Recruitment Status : Completed
First Posted : January 29, 2010
Results First Posted : April 24, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Tillotts Pharma AG

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Mesalamin Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mesalamin
4.8g Mesalamin (800mg tablet)
Drug: Mesalamin
4.8g/day, 800 mg tablets
Other Name: Asacol

Placebo Comparator: Placebo
4.8g Placebo to Mesalamin (800 mg tablet)
Drug: Mesalamin
4.8g/day, 800 mg tablets
Other Name: Asacol




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Clinical Remission [ Time Frame: 10 weeks ]
    Clinical remission defined as a score of 0 for stool frequency, 0 for rectal bleeding and no urgency

  2. Endoscopic Remission [ Time Frame: 6 weeks ]
    Endoscopic remission is defined as a sigmoidoscopy score of 1 or less

  3. Endoscopic Remission [ Time Frame: 10 weeks ]
    Endoscopic remission is defined as a sigmoidoscopy score of 1 or less

  4. 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)

  5. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059344


Locations
Show Show 31 study locations
Sponsors and Collaborators
Tillotts Pharma AG
Investigators
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Study Chair: Brian Feagan, MD Robarts Clinical Trials Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tillotts Pharma AG
ClinicalTrials.gov Identifier: NCT01059344    
Other Study ID Numbers: TP0203
First Posted: January 29, 2010    Key Record Dates
Results First Posted: April 24, 2017
Last Update Posted: August 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tillotts Pharma AG:
Mesalamine
Asacol
Ulcerative colitis
induction therapy
acute disease
mild to moderate
Active Ulcerative Colitis (mild to moderate)
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents