A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III

• Conditions: lcerative Colitis; MedDRA version: 8.1Classification code 10009900

• Registration Number: EUCTR2006-001310-32-HU
• Lead Sponsor: Procter & Gamble Technical Centres Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 770

Inclusion Criteria

Patients, who
a) are willing and able to provide written informed consent;
b) are male or female between 18 and 75 years of age, inclusive, at Screening;
c) have a confirmed diagnosis of moderately active ulcerative colitis, extending proximally beyond 15 cm from the anal verge, as confirmed by flexible sigmoidoscopy or colonoscopy performed within 7 days prior to the Baseline Visit.
d) have a confirmed diagnosis of moderately active disease (PGA = 2, see Appendix 7.7) at the Baseline Visit;
e) have, at the Baseline Visit, a score of at least 1 in both the stool frequency and rectal bleeding clinical assessments and a score of at least 2 in the Sigmoidoscopy Assessment Score (Appendix 7.3);
f) if female, must be (as documented by verbally offered medical history):
• postmenopausal (at least 1 year without spontaneous menses), or
• surgically sterile (tubal ligation or hysterectomy at least 6 months prior to
enrollment), or
• using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal
contraception [at least 3 months prior to enrollment], sexual partner with nonreversed vasectomy [with azoospermia in 2 tests], 2 barrier methods [e.g., condom, diaphragm, or spermicide], or intra-uterine device). Women who are using
contraception will be required to have a pregnancy test (urine or serum) at the
Screening Visit and at the Week 6/Exit Visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients, who have/are
a) received a dose of a product that contains or is metabolized to mesalamine by any route from which more than 1.6 g/day of mesalamine was available within 7 days before the Screening Visit;
b) UC confined to rectum (isolated ulcerative proctitis);
c) a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any component of the Asacol tablet;
d) a history or presence of any condition causing malabsorption or an effect on
gastrointestinal motility or history of extensive small bowel resection (greater than one half the length of the small intestine) causing short bowel syndrome;
e) a current abuser of drugs or alcohol;
f) a history of HIV infection or AIDS;
g) a significant co-existing illness or other condition(s) that, in the judgment of the
Investigator, contraindicate(s) administration of the study drug and/or any study
procedures;
h) current renal disease (serum creatinine more than 1.5 times the upper limit of normal at Screening Visit) or documented history of hepatic disease (aspartate transaminase [AST] or alanine transaminase [ALT] more than 2 times the upper limit of normal);
i) previously participated in this study;
j) participated in any drug or device clinical study within 30 days before study entry;
k) currently enrolled in any other clinical study;
l) received any oral, intravenous, intramuscular, or rectally administered corticosteroids (including budesonide) within 30 days before the Screening Visit;
m) received any other topical rectal therapy during the 7 days before the Screening Visit;
n) received immunomodulatory therapy including, but not limited to, rosiglitazone,
6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 90 days before the Screening Visit;
o) received infliximab, certolizumab, or other biologic treatment of ulcerative colitis within 90 days before the Screening Visit;
p) received antibiotics, other than topical antibiotics, within 7 days before the Screening Visit;
q) used any product containing omega-3 (fish) oils within 7 days before the Screening Visit;
r) received aspirin (except for cardioprotective reasons up to a maximum dose of
325 mg/day) or other NSAIDs within 7 days before the Screening Visit;
s) received any anti-diarrheals, and/or anti-spasmodics within 3 days before the Screening Visit;
t) stool examination positive for Clostridium difficile, bacterial pathogens, or ova and
parasites;
u) if female, positive pregnancy test (serum or urine) or lactating

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified