A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis

NCT01045018 | Completed Phase 3

• 1 other identifier: EMET 001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mild to Moderate Ulcerative Colitis

Keywords

colitis; ulcerative; ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• 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

  4 months

Secondary Outcomes (1)

• Tolerability and safety will be determined by evaluation of AEs, SAEs, hematology, serum chemistry and urinalysis

  4 months

Study Arms (3)

mesalamine 400 mg tablet

ACTIVE COMPARATOR

Drug: Mesalamine

Asacol 400 mg Delayed Release Tablet

ACTIVE COMPARATOR

Drug: Mesalamine

Placebo delayed release tablet

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

placebo 400 mg

Placebo delayed release tablet

Mesalamine DRUG

mesalamine 400 mg tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EMET Pharmaceuticals, LLC: lead
• Eagle Pharmaceuticals, Inc.: collaborator

MeSH Terms

Conditions

Colitis; Ulcer; Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammatory Bowel Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: January 8, 2010
• Study Start: January 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 8, 2010

Record last verified: 2009-12