A Multicenter, Double-blind, Controlled, Randomized, Parallel Group Comparison Phase IIIa Treatment Investigation on the Efficacy and Safety of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
Hypothesis: The responder rate of the MAX-002 will be superior to placebo after 6 weeks of
treatment in patients with mild to moderate ulcerative proctitis.
Summary: The primary purpose of this study is to evaluate the efficacy and safety of new
mesalamine suppositories (MAX-002) as compared to placebo after 6 weeks of treatment in
adults with mild to moderate ulcerative proctitis.
Prior to randomization, all inclusion and exclusion criteria will be verified to confirm
eligibility. Patients found to be eligible will be randomized in a 1:1:1 scheme to receive
either MAX-002 1 g, Canasa® 1 g, or Placebo suppository once daily at bedtime for 6 weeks in
a double-blind fashion. Completers at Study Week 6 will be offered to receive MAX-002 1 g
suppositories on a voluntary basis during the next 8 weeks of the open-label phase.
Regardless of the treatment groups, all patients will be evaluated through phone calls at
Study Weeks 1 and 2 followed by clinical visits at Study Weeks 3, 6, and 14. Study-specific
procedures include but are not limited to the following: flexible proctosigmoidoscopy;
disease activity assessment; smoking habits description; health-related quality of life;
compliance to treatment check and safety evaluations (physical examinations, ECG, vitals
signs, clinical laboratory analyses). All patients will complete daily diaries and will be
asked general open questions about any occurrence of adverse events/concurrent medical
conditions, use of adjunctive therapy/procedure, and their intake of concomitant medication.
Study Status: Terminated
Information provided by:
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cleveland, Ohio 44195
Marielle Cohard-Radice, M.D.., Study Director