Efficacy and Safety Study of MAX-002 Suppository Versus Placebo in Mild to Moderate Ulcerative Proctitis

Status:	Terminated
Conditions:	Colitis, Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - Any
Updated:	10/14/2017
Start Date:	September 2009
End Date:	September 2011

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.

Main Inclusion Criteria:

- At screening, patients must have confirmation of mild to moderate UP not extending
above the rectum with a total Mayo DAI score between 5 and 10, inclusively.

- Score of 2 or more for the "Rectal bleeding" and for the "Findings of flexible
proctosigmoidoscopy or colonoscopy" sub-scores of the Mayo DAI.

Main Exclusion Criteria:

- Presence of other digestive diseases interfering with the measurement of any sub-score
of the DAI.

- Known presence or suspicion of malignant disease of the digestive system or presence
or history of neoplasms other than carcinoma in situ of the cervix or basal carcinoma
of the skin.

- Chronic use of oral 5-aminosalicylic acid (5-ASA) at a dose greater than 4 g daily,
change in the oral 5-ASA dosing, or use of any form of rectal 5-ASA formulations
during the 30 days prior to randomization.

- Significant use of corticosteroids that may have a therapeutic effect on UP,
immunosuppressants or biologic response modifiers during the 45 days prior to the date
of consent.

- Use of any rectally administered medicine during the 30 days prior to randomization.

- Presence of other known clinically significant medical and/or psychological illnesses
precluding participation.

We found this trial at

sites

Research Associates of New York (RANY)

New York, New York 10075

from

New York, NY