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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: May 29, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
Ulcerative Colitis Drug: Mesalamin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tillotts Pharma AG:

Primary Outcome Measures:
  • 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:
  • Clinical Remission [ Time Frame: 10 weeks ]
    Clinical remission defined as a score of 0 for stool frequency, 0 for recral 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)


Enrollment: 281
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059344

Locations
Belarus
Gomel Regional Clinical Hospital, 9
Gomel, Belarus, 23602
City Clinical Hospital No.1
Minsk, Belarus, 220013
Minsk Regional Clinical Hospital, 41
Minsk, Belarus, 2230
City Clinical Hospital No. 2
Minsk, Belarus
E.Klumov City Clinical Hospital No. 3
Minsk, Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, Belarus, 210037
India
Medwin Hospital
Hyderabad, Andhrapradesh, India, 500 001
Osmania General Hospital
Hyderabad, Andhrapradesh, India, 500 012
M.S.Ramiah Hospital
Bangalore, Karnataka, India, 560 054
Shree Gokulam Medical College and Research Foundation
Trivandrum, Kerala, India, 695 607
S. R. Kalla Memorial Gastro and General Hospital
Jaipur, Rajasthan, India, 302 001
Life Line Hospital
Chennai, TamilNadu, India, 600 096
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi, India, 110 002
Institute of liver and billiary sciences
New Delhi, India, 110 070
Turkey
Ankara University Medical Faculty Sihhiye
Ankara, Turkey, 06100
Hacettepe University Medical Faculty Sihhiye
Ankara, Turkey, 06100
Gazi University Medical Faculty Besevler
Ankara, Turkey, 06500
Dicle University Medical Faculty
Diyarbakir, Turkey, 21280
Trakya University Medical Faculty
Edirne, Turkey, 22030
Gaziantep University Medical Faculty Kampus Alani
Gaziantep, Turkey, 27310
Sisli Etfal Egitim ve Arastirma Hospital Sisli
Istanbul, Turkey, 34360
Dokuz Eylul University Medical Faculty Inciralti
Izmir, Turkey, 35340
Ataturk Egitim ve Arastirma Hospital Basin Sitesi
Izmir, Turkey, 35360
Ukraine
Dnipropetrovska derzhavna medychna akademiia,
Dnipropetrovsk, Ukraine, 4904
Ivano-Frankivskyi natsionalnyi medychnyi universytet,
Ivano-Frankivsk, Ukraine
Miska klinichna likarnia 2,
Kharkiv, Ukraine, 61001
Natsionalnyi medychnyi universytet im. Bogomoltsia, kafedra khirurgii 1 na bazi viddilennia proctologii Miskoi klinichnoi likarni 18, m.Kyiv
Kyiv, Ukraine, 01030
Natsionalnyi medychnyi universytet im. O.O. Bogomoltsia,
Kyiv, Ukraine, 04053
Natsionalna medychna akademia pisliadyplomnoi osvity im. P.L. Shupyk,
Kyiv, Ukraine, 04201
Lvivskyi natsionalnyi medychnyi universytet imeni Danyla Galytskogo,
Lviv, Ukraine
Odeska oblasna klinichna likarnia, Oblasnyi tsentr gastroenterologii,
Odessa, Ukraine, 65039
Sponsors and Collaborators
Tillotts Pharma AG
Investigators
Study Chair: Brian Feagan, MD Robarts Clinical Trials
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tillotts Pharma AG
ClinicalTrials.gov Identifier: NCT01059344     History of Changes
Other Study ID Numbers: TP0203
Study First Received: January 28, 2010
Results First Received: October 24, 2016
Last Updated: May 29, 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:
Colitis
Ulcer
Colitis, Ulcerative
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

ClinicalTrials.gov processed this record on July 19, 2017