119
Participants
Start Date
November 30, 2009
Primary Completion Date
July 31, 2011
Study Completion Date
September 30, 2011
MAX-002
MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the open-label (OL) phase.
Placebo
Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
Canasa®
Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
Research Associates of New York (RANY), New York
Synergy First Medical, Brooklyn
Digestive Research Associates, Newnan
Shafran Gastroenterology Center, Winter Park
Center for Gastrointestinal Disorders, Hollywood
Clinical Research of South Florida, Boynton Beach
Gastroenterology Group of Naples, Naples
Birmingham Gastroenterology Associates P.C., Birmingham
Digestive Health Specialists of the Southeast, Dothan
The First Clinic, Nashville
Memphis Gastroenterology Group, Germantown
Gastrointestinal Associates, Jackson
Cleveland Clinic, Cleveland
Consultants for Clinical Research, Cincinnati
Advanced Pain Care Clinic, Evansville
Wisconsin Center for Advanced Research, Milwaukee
Center for Digestive & Liver Diseases Inc., Mexico
South Texas Research Alliance, Laredo
Rocky Mountain Gastroenterology Associates, Thornton
Desert Sun Gastroenterology, Tucson
Litchfield County Gastroenterology and Associates, Torrington
South Jersey Gastroenterology, Marlton
Gastroenterology & Hepatology Clinic, Abbotsford
Diamond Health Care Centre, Vancouver
Surrey GI Clinic Research, Guelph
St-Joseph's Healthcare Hamilton, Hamilton
DHC Research, Richmond Hill
Toronto Digestive Disease Associates Inc. (TDDA), Vaughan
Hôpital Maisonneuve-Rosemont, Montreal
Alpha Recherche Clinique, Québec
GASTROMED s.c., Bialystok
Wojewódzki Szpital Specjalistyczny Oddz. Gastroenterologii, Częstochowa
SPZOZ Uniwersytecki Szpital Kliniczny, Lodz
SPZOZ Uniwersytecki Szpital Kliniczny, Lodz
Wojewodzki Szpital Specjalistyczny, Lublin
SP Szpital Kliniczny, Lublin
Szpital Kolejowy, Pruszków
MEDICOR - Centrum Medyczne, Rzeszów
Endoskopia SP. Z o.o., Sopot
Gabinet Lekarski LECHMED, Warsaw
Lead Sponsor
Forest Laboratories
INDUSTRY