- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01045018
A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis
January 7, 2010 updated by: EMET Pharmaceuticals, LLC
BE Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400 mg to the Reference Listed Drug ASACOL® Delayed Release Tablets 400 mg in Patients With Mild to Moderately Active Ulcerative Colitis
The objectives of this bioequivalence study in patients with ulcerative colitis (UC) were:
- To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol Delayed Release Tablets 2.4 g per day (800 mg three times daily) and
- To evaluate the safety of MDRT 2.4 g per day (800 mg three times daily) compared to placebo.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This was a multi-center, randomized, parallel-groups comparison of two mesalamine products for treatment of ulcerative colitis.
Patients were randomly assigned in an optimized 2:2:1 ratio to MDRT 2.4 g/day, Asacol 2.4 g/day, or placebo.
The study was partially blinded due to the difficulties associated with creating placebo that matched both MDRT and Asacol; the placebo matched the MDRT formulation.
Placebo groups served as control in the parallel group comparison between MDRT and Asacol.
Patients were treated for 6 weeks after randomization and followed through Day 56, which was considered of sufficient length to accommodate any safety issues and to assess efficacy based upon prior clinical trials of mesalamine in patients with mild to moderate active UC as described in the introduction
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Adults with newly diagnosed ulcerative colitis or with relapse following prior treatment and who met all the following criteria were eligible for participation in the study:
- IRB approved consent form signed and dated prior to any study-related activities
- Male or, if female, had undergone sterilization (hysterectomy or bilateral tubal ligation), was post-menopausal (defined as 1 year without menses) or has a negative pregnancy test at screening and, if heterosexually active, had used and agreed to continue to use: double-barrier method of contraception (condom and spermicide), oral or patch contraceptives, intrauterine device, or was in a monogamous relationship with a partner who had undergone a vasectomy.
- 18 years of age or older
- Newly diagnosed with ulcerative colitis or relapsed following prior treatment
- Patient had 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 Disease Activity Index (DAI) score between 4 and 9, inclusive, at study entry, and with a PGA of 1 or 2 and mucosal appearance (determined by endoscopy exam) score of 1 or 2 (mild/moderate)
- Able and willing to have kept a daily diary during the study
Exclusion Criteria:
- Treatment with topical rectal, oral, or intravenous (IV) corticosteroids within 30 days of screening or immunosuppressives (e.g. azathioprine, 6-mercaptopurine) within the 90 days immediately preceding Screening
- Use of rectal - administered aminosalicylates within 7 days of randomization
- Patient had taken greater than 1.6 g/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 precluded 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
- Used an investigational drug in the 30 days prior to randomization
- BUN or serum creatinine levels of 1.5 times the upper limit of normal (ULN) or liver enzyme levels > 2 times the ULN
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: mesalamine 400 mg tablet
|
|
ACTIVE_COMPARATOR: Asacol 400 mg Delayed Release Tablet
|
|
PLACEBO_COMPARATOR: Placebo delayed release tablet
|
placebo 400 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment Success: Responders are patients in remission or who do not require use of rescue medication for symptomatic relief of UC at week 6 Treatment benefit: Improvement at endpoint compared to baseline Treatment Failure: Increase or no improvement
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tolerability and safety will be determined by evaluation of AEs, SAEs, hematology, serum chemistry and urinalysis
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (ACTUAL)
June 1, 2009
Study Completion (ACTUAL)
August 1, 2009
Study Registration Dates
First Submitted
December 17, 2009
First Submitted That Met QC Criteria
January 7, 2010
First Posted (ESTIMATE)
January 8, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
January 8, 2010
Last Update Submitted That Met QC Criteria
January 7, 2010
Last Verified
December 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Ulcer
- Colitis
- Colitis, Ulcerative
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Mesalamine
Other Study ID Numbers
- EMET 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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