E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to moderately active ulcerative colitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009900 |
E.1.2 | Term | Colitis ulcerative |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol Delayed Release Tanlets 2.4g per day (800 mg three times daily) |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of mesalamine delayed releae tablets 2.4g per day (800mg three times daily) compared to placebo |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 1.6 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.
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E.5 End points |
E.5.1 | 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 UC 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 in sigmoidoscopy score, worsening or no improvement in the number of bowel movements, rectal bleeding, and worsening or no improvement in other symptoms.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Described in the study protocol |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 24 |