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

NCT01059344 | Completed Phase 3 Results

• 1 other identifier: TP0203
• Study Type: interventional
• Target: 281
• Locations: 4 countries
• Sites: 31

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).

Conditions

Ulcerative Colitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC).

  Clinical remission defined as stool frequency score of 0, rectal bleeding score of 0, no urgency

  6 weeks

Secondary Outcomes (5)

• Clinical Remission

  10 weeks

• Endoscopic Remission

  6 weeks

• Endoscopic Remission

  10 weeks

• Improvement

  6 weeks

• Improvement

  10 weeks

Study Arms (2)

Mesalamin

EXPERIMENTAL

4.8g Mesalamin (800mg tablet)

Drug: Mesalamin

Placebo

PLACEBO COMPARATOR

4.8g Placebo to Mesalamin (800 mg tablet)

Drug: Mesalamin

Interventions

Mesalamin DRUG

4.8g/day, 800 mg tablets

Also known as: Asacol

Mesalamin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• Severe UC defined by the following criteria:
• ³6 bloody stools daily with one or more of the following:
• oral temperature \> 37.8°C or \> 100.0°F
• pulse \> 90/min
• hemoglobin \< 10 g/dL
• Previously failed treatment with a mesalazine dose of \> 2.0 g/day.
• Current relapse lasting \> 6 weeks in the opinion of the investigator.
• Treatment with 5-ASA at a dose of \>2.0g/day within 1 week prior to randomisation
• Treatment with systemic or rectal steroids within 4 weeks prior to randomization.
• Treatment with immunosuppressants within 6 weeks prior to randomization.
• Treatment with infliximab or other biologics within 3 months prior to randomization.
• Treatment with systemic antibiotics for UC within 7 days prior to randomization.
• Treatment with probiotics within 7 days prior to randomization.
• Treatment with anti-diarrheals within 7 days prior to randomization.
• Treatment with nicotine patch within 7 days prior to randomization.

Sponsors & Collaborators

• Tillotts Pharma AG: lead

Study Sites (31)

Gomel Regional Clinical Hospital, 9

Homyel, 23602, Belarus

Location

City Clinical Hospital No.1

Minsk, 220013, Belarus

Location

Minsk Regional Clinical Hospital, 41

Minsk, 2230, Belarus

Location

City Clinical Hospital No. 2

Minsk, Belarus

Location

E.Klumov City Clinical Hospital No. 3

Minsk, Belarus

Location

Vitebsk Regional Clinical Hospital

Vitebsk, 210037, Belarus

Location

Medwin Hospital

Hyderabad, Andhrapradesh, 500 001, India

Location

Osmania General Hospital

Hyderabad, Andhrapradesh, 500 012, India

Location

M.S.Ramiah Hospital

Bangalore, Karnataka, 560 054, India

Location

Shree Gokulam Medical College and Research Foundation

Trivandrum, Kerala, 695 607, India

Location

S. R. Kalla Memorial Gastro and General Hospital

Jaipur, Rajasthan, 302 001, India

Location

Life Line Hospital

Chennai, Tamil Nadu, 600 096, India

Location

Maulana Azad Medical College and Associated Lok Nayak Hospital

New Delhi, 110 002, India

Location

Institute of liver and billiary sciences

New Delhi, 110 070, India

Location

Ankara University Medical Faculty Sihhiye

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty Sihhiye

Ankara, 06100, Turkey (Türkiye)

Location

Gazi University Medical Faculty Besevler

Ankara, 06500, Turkey (Türkiye)

Location

Dicle University Medical Faculty

Diyarbakır, 21280, Turkey (Türkiye)

Location

Trakya University Medical Faculty

Edirne, 22030, Turkey (Türkiye)

Location

Gaziantep University Medical Faculty Kampus Alani

Gaziantep, 27310, Turkey (Türkiye)

Location

Sisli Etfal Egitim ve Arastirma Hospital Sisli

Istanbul, 34360, Turkey (Türkiye)

Location

Dokuz Eylul University Medical Faculty Inciralti

Izmir, 35340, Turkey (Türkiye)

Location

Ataturk Egitim ve Arastirma Hospital Basin Sitesi

Izmir, 35360, Turkey (Türkiye)

Location

Dnipropetrovska derzhavna medychna akademiia,

Dnipropetrovsk, 4904, Ukraine

Location

Ivano-Frankivskyi natsionalnyi medychnyi universytet,

Ivano-Frankivsk, Ukraine

Location

Miska klinichna likarnia 2,

Kharkiv, 61001, Ukraine

Location

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

Kyiv, 01030, Ukraine

Location

Natsionalnyi medychnyi universytet im. O.O. Bogomoltsia,

Kyiv, 04053, Ukraine

Location

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

Kyiv, 04201, Ukraine

Location

Lvivskyi natsionalnyi medychnyi universytet imeni Danyla Galytskogo,

Lviv, Ukraine

Location

Odeska oblasna klinichna likarnia, Oblasnyi tsentr gastroenterologii,

Odesa, 65039, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 23528626 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Acute Disease

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Limitations and Caveats

Investigator endoscopy scores resultet in 31% patients with insuficient disease severity at baseline. Central reader scores were used for a post hoc analysis of the primary endpoint, including patients with pre-specified disease severity only.

Results Point of Contact

• Title: Brian G. Feagan et al
• Organization: The Role of Centralized Reading of Endoscopy in a Randomized Controlled Trial of Mesalamine for Ulcertive Colitis

Gastroenterology 2013; 145:

Study Officials

• Brian Feagan, MD

  Alimentiv Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: January 29, 2010
• Study Start: November 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 2, 2017
• Results First Posted: April 24, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (9); IN (8); BE (6); UA (8)