Ulcerative Colitis MedDRA version: 8.1 Classification code 10009900
Conditions
Interventions
Product Name: Asacol 800 mg tablet
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: mesalazine
Current Sponsor code: mesalamine (USAN)
Other descriptive name: 5-aminosalicylic acid (5
Sponsors
Procter & Gamble Technical Centres Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the clinical benefits of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in patients with moderately active ulcerative colitis using the Physician’s Global Assessment (PGA).;Secondary Objective: - To evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in male patients with moderately active UC; - To evaluate the change in each of the individual assessments and composite scores (PGA and modified Mayo Score) at Week 6; - To evaluate the change in the individual assessments of stool frequency, rectal bleeding, and PFA at Week 3; - To evaluate treatment success in patients with left-sided disease at Week 6.;Primary end point(s): The primary efficacy endpoint will be the proportion of patients in each treatment group who achieve treatment success, defined as improvement from baseline at Week 6. Improvement is defined as either a complete response (remission) or a partial response (improvement) to treatment. A complete response is defined as a Physician’s Global Assessment (PGA) of zero (PGA = 0), i.e., complete resolution or normalization of all of the following: stool frequency, rectal bleeding, and Sigmoidoscopy Assessment Score. A partial response is defined as improvement from baseline in the PGA and no worsening in any of the 3 component endpoints. | — |
Countries
Czech Republic, Estonia, Hungary, Latvia, Lithuania
Outcome results
None listed