Mild to moderately active ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative
Conditions
Interventions
Product Name: Mesalamine Delayed Release Tablets 400mg
Pharmaceutical Form: Tablet
INN or Proposed INN: MESALAZINE
CAS Number: 89576
Current Sponsor code: QBC01
Concentration unit: mg milligram(s)
Con
Sponsors
EMET Pharmaceuticals LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •IRB approved consent form signed and dated prior to any study-related activities •Male or, if female, has undergone sterilization (hysterectomy or bilateral tubal ligation), is post-menopausal (defined as 1 year without menses) or has a negative pregnancy test at screening and, if heterosexually active, has used and agrees to continue to use; double-barrier method of contraception (condom and spermicide), oral or patch contraceptives, intrauterine device, or is in a monogamous relationship with a partner who has undergone a vasectomy. The investigator/designee will be responsible for determining appropriate usage of birth control for study participation •18 years of age or older •Newly diagnosed with ulcerative colitis or relapsed following prior treatment •Patient has not taken > 1.6 g/day of mesalamine or equivalent for 14 days prior to randomization •Disease extending = 15 cm above the anal verge on screening sigmoidoscopy or colonoscopy with confirming biopsy •Mild to moderate ulcerative colitis, defined as a DAI score between 4 and 9, inclusive, at study entry. Patient must also have a PGA of 1 or 2 and mucosal appearance (determined by endoscopy exam) score of 1 or 2 (mild/moderate) •Patient must be able and willing to keep a daily diary during the study 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: •Treatment with topical rectal, oral, or intravenous (IV) corticosteroids within 30 days of screening or immunosuppressives (e.g. azothioprine, 6-mercaptopurine) within the 90 days immediately preceding Screening •Use of rectal - administered aminosalicylates within 7 days of randomization •Subject has taken greater than 1.2 grams/day of mesalamine or equivalent within 14 days of randomization •Crohn’s disease, ischemic colitis, or disease of bacterial origin •Known allergy or hypersensitivity to aspirin or salicylate compounds •History of or laboratory results showing significant hepatic or renal disease or other significant medical condition which in the opinion of the investigator precludes participation in the study based on efficacy/safety assessments •History of cancer other than basal cell carcinoma within the five years immediately preceding study entry •In relapse for > 3 weeks prior to the screening visit •Proctitis below 15 cm from the anal verge •History of or current gastrointestinal bleeding other than bloody stools associated with ulcerative colitis •History of Bleeding disorder •Active peptic ulcer disease, history of gastrointestinal obstruction including severe constipation, or anatomic abnormality of the GI tract •Previous colonic surgery •History of alcohol or other substance abuse within the year immediately preceding anticipated study entry •HIV positive •> 6 bloody stools per day •Positive stool culture for ova and/or parasites, enteric pathogens including Salmonella, Shigella, Yersinia, and Campylobacter, or positive stool assay for C. difficile toxin •Pregnant or breast feeding •Use of an investigational drug in the 30 days prior to randomization •Patient has BUN or serum creatinine levels of 1.5 times the upper limit of normal (ULN) or liver enzyme levels > 2 times the ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol® Delayed Release Tablets 2.4g per day (800mg three times daily);Secondary Objective: To evaluate the safety of mesalamine delayed release tablets 2.4g per day (800mg three times daily) compared to placebo;Primary end point(s): The primary outcome measure will be the determination of treatment success or treatment failure: Treatment success: Responders are patients in remission (all symptom scores are zero) or improved who do not require use of rescue medication for symptomatic relief of ulcerative colitis at week 6. Patients will be considered improved if the Physician’s Global Assessment (PGA) improves by at least one class, mucosal appearance improves by at least one category, and there is no worsening in any other scores. Treatment failure: Increase or no improvement in sigmoidoscopy score, worsening or no improvement in the number of bowel movements, and severity of rectal bleeding, and worsening or no improvement in other symptoms. | — |
Countries
Estonia, Latvia, Poland
Outcome results
None listed