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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059344
• Other study ID #: TP0203
• Status: Completed
• Phase: Phase 3
• First received: January 28, 2010
• Last updated: September 16, 2013
• Start date: November 2009
• Est. completion date: August 2011

Study information

• Verified date: April 2013
• Source: Tillotts Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ukraine: Ministry of HealthUkraine: State Pharmacological Center - Ministry of HealthBelarus: Ministry of HealthTurkey: Ethics CommitteeTurkey: Ministry of HealthIndia: Institutional Review BoardIndia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Mesalamin
4.8g/day, 800 mg tablets

Locations

Country	Name	City	State
Belarus	Gomel Regional Clinical Hospital, 9	Gomel
Belarus	City Clinical Hospital No. 2	Minsk
Belarus	City Clinical Hospital No.1	Minsk
Belarus	E.Klumov City Clinical Hospital No. 3	Minsk
Belarus	Minsk Regional Clinical Hospital, 41	Minsk
Belarus	Vitebsk Regional Clinical Hospital	Vitebsk
India	M.S.Ramiah Hospital	Bangalore	Karnataka
India	Life Line Hospital	Chennai	TamilNadu
India	Medwin Hospital	Hyderabad	Andhrapradesh
India	Osmania General Hospital	Hyderabad	Andhrapradesh
India	S. R. Kalla Memorial Gastro and General Hospital	Jaipur	Rajasthan
India	Institute of liver and billiary sciences	New Delhi
India	Maulana Azad Medical College and Associated Lok Nayak Hospital	New Delhi
India	Shree Gokulam Medical College and Research Foundation	Trivandrum	Kerala
Turkey	Gazi University Medical Faculty Besevler	Besevler-Ankara
Turkey	Dicle University Medical Faculty	Diyarbakir
Turkey	Trakya University Medical Faculty	Edirne
Turkey	Gaziantep University Medical Faculty Kampus Alani	Gaziantep
Turkey	Dokuz Eylul University Medical Faculty Inciralti	Inciralti-Izmir
Turkey	Sisli Etfal Egitim ve Arastirma Hospital Sisli	Istanbul
Turkey	Ataturk Egitim ve Arastirma Hospital Basin Sitesi	Izmir
Turkey	Ankara University Medical Faculty Sihhiye	Sihhiye-Ankara
Turkey	Hacettepe University Medical Faculty Sihhiye	Sihhiye-Ankara
Ukraine	Dnipropetrovska derzhavna medychna akademiia,	Dnipropetrovsk
Ukraine	Ivano-Frankivskyi natsionalnyi medychnyi universytet,	Ivano-Frankivsk
Ukraine	Miska klinichna likarnia 2,	Kharkiv
Ukraine	Natsionalna medychna akademia pisliadyplomnoi osvity im. P.L. Shupyk,	Kyiv
Ukraine	Natsionalnyi medychnyi universytet im. Bogomoltsia, kafedra khirurgii 1 na bazi viddilennia proctologii Miskoi klinichnoi likarni 18, m.Kyiv	Kyiv
Ukraine	Natsionalnyi medychnyi universytet im. O.O. Bogomoltsia,	Kyiv
Ukraine	Lvivskyi natsionalnyi medychnyi universytet imeni Danyla Galytskogo,	Lviv
Ukraine	Odeska oblasna klinichna likarnia, Oblasnyi tsentr gastroenterologii,	Odessa

Sponsors (1)

Lead Sponsor	Collaborator
Tillotts Pharma AG

Countries where clinical trial is conducted

Belarus,  India,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		6 weeks	No
Secondary	? 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		10 weeks	No