Phase 3 N=281 Randomized Quadruple-blind Treatment

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

Ulcerative Colitis

Bottom Line

View on ClinicalTrials.gov: NCT01059344 ↗

Enrolled (actual)

281

Serious AEs

1.1%

Results posted

Apr 2017

Primary outcome: Primary: To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). — 42; 29 participants — p=0.069

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Mesalamin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tillotts Pharma AG
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC).	42; 29	0.069
SECONDARY Clinical Remission	57; 30	<0.001 sig
SECONDARY Endoscopic Remission	73; 52	0.010 sig
SECONDARY Endoscopic Remission	73; 52	0.010 sig
SECONDARY Improvement	88; 57	<0.001 sig
SECONDARY Improvement	88; 57	<0.001 sig

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).

Eligibility 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

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 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.
Received any investigational drug within 30 days prior to randomization.
History of colectomy or partial colectomy.
History of definite dysplasia in colonic biopsies.
Crohn's disease.
Known bleeding disorders.
Immediate or significant risk of toxic megacolon.
Hypersensitivity to salicylates, aspirin, sulfasalazine or 5-ASA.
Serum creatinine > 1.5 times the upper limit of the normal range.
AST, ALT, total bilirubin or alkaline phosphatase > 2 times the upper limit of the normal range.
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.
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.
Stools positive for clostridium difficile.
Pregnant or lactating women.
Prior enrolment in the current study and had received study treatment.

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Data sourced from ClinicalTrials.gov (NCT01059344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.