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

NCT ID: NCT01059344

Last Updated: 2017-08-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-08-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Ulcerative Colitis

Keywords

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Mesalamine Asacol Ulcerative colitis induction therapy acute disease mild to moderate Active Ulcerative Colitis (mild to moderate)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mesalamin

4.8g Mesalamin (800mg tablet)

Group Type EXPERIMENTAL

Mesalamin

Intervention Type DRUG

4.8g/day, 800 mg tablets

Placebo

4.8g Placebo to Mesalamin (800 mg tablet)

Group Type PLACEBO_COMPARATOR

Mesalamin

Intervention Type DRUG

4.8g/day, 800 mg tablets

Interventions

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Mesalamin

4.8g/day, 800 mg tablets

Intervention Type DRUG

Other Intervention Names

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Asacol

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tillotts Pharma AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Feagan, MD

Role: STUDY_CHAIR

Alimentiv Inc.

Locations

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Gomel Regional Clinical Hospital, 9

Homyel, , Belarus

Site Status

City Clinical Hospital No.1

Minsk, , Belarus

Site Status

Minsk Regional Clinical Hospital, 41

Minsk, , Belarus

Site Status

City Clinical Hospital No. 2

Minsk, , Belarus

Site Status

E.Klumov City Clinical Hospital No. 3

Minsk, , Belarus

Site Status

Vitebsk Regional Clinical Hospital

Vitebsk, , Belarus

Site Status

Medwin Hospital

Hyderabad, Andhrapradesh, India

Site Status

Osmania General Hospital

Hyderabad, Andhrapradesh, India

Site Status

M.S.Ramiah Hospital

Bangalore, Karnataka, India

Site Status

Shree Gokulam Medical College and Research Foundation

Trivandrum, Kerala, India

Site Status

S. R. Kalla Memorial Gastro and General Hospital

Jaipur, Rajasthan, India

Site Status

Life Line Hospital

Chennai, Tamil Nadu, India

Site Status

Maulana Azad Medical College and Associated Lok Nayak Hospital

New Delhi, , India

Site Status

Institute of liver and billiary sciences

New Delhi, , India

Site Status

Ankara University Medical Faculty Sihhiye

Ankara, , Turkey (Türkiye)

Site Status

Hacettepe University Medical Faculty Sihhiye

Ankara, , Turkey (Türkiye)

Site Status

Gazi University Medical Faculty Besevler

Ankara, , Turkey (Türkiye)

Site Status

Dicle University Medical Faculty

Diyarbakır, , Turkey (Türkiye)

Site Status

Trakya University Medical Faculty

Edirne, , Turkey (Türkiye)

Site Status

Gaziantep University Medical Faculty Kampus Alani

Gaziantep, , Turkey (Türkiye)

Site Status

Sisli Etfal Egitim ve Arastirma Hospital Sisli

Istanbul, , Turkey (Türkiye)

Site Status

Dokuz Eylul University Medical Faculty Inciralti

Izmir, , Turkey (Türkiye)

Site Status

Ataturk Egitim ve Arastirma Hospital Basin Sitesi

Izmir, , Turkey (Türkiye)

Site Status

Dnipropetrovska derzhavna medychna akademiia,

Dnipropetrovsk, , Ukraine

Site Status

Ivano-Frankivskyi natsionalnyi medychnyi universytet,

Ivano-Frankivsk, , Ukraine

Site Status

Miska klinichna likarnia 2,

Kharkiv, , Ukraine

Site Status

Natsionalnyi medychnyi universytet im. Bogomoltsia, kafedra khirurgii 1 na bazi viddilennia proctologii Miskoi klinichnoi likarni 18, m.Kyiv

Kyiv, , Ukraine

Site Status

Natsionalnyi medychnyi universytet im. O.O. Bogomoltsia,

Kyiv, , Ukraine

Site Status

Natsionalna medychna akademia pisliadyplomnoi osvity im. P.L. Shupyk,

Kyiv, , Ukraine

Site Status

Lvivskyi natsionalnyi medychnyi universytet imeni Danyla Galytskogo,

Lviv, , Ukraine

Site Status

Odeska oblasna klinichna likarnia, Oblasnyi tsentr gastroenterologii,

Odesa, , Ukraine

Site Status

Countries

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Belarus India Turkey (Türkiye) Ukraine

References

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Feagan BG, Sandborn WJ, D'Haens G, Pola S, McDonald JWD, 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.

Reference Type DERIVED
PMID: 23528626 (View on PubMed)

Other Identifiers

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TP0203

Identifier Type: -

Identifier Source: org_study_id