Clinical trial NCT01016262: Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Proctitis, Ulcerative
Keywords: Ulcerative proctitis
Proctocolitis
Inflammatory Bowel Disease
Gastrointestinal Diseases
Colonic Diseases
Mesalamine
5-ASA
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2009-11-19
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo and active medicine after 6 weeks of treatment in adults with mild to moderate ulcerative proctitis (UP).

Detailed description: The present study consists of screening period (2 weeks before randomization), DB phase (6 weeks), OL phase (8 weeks) and follow-up visits at Week 3, Week 6 and Week 14. Participants who are eligible will be randomized to receive 1g MAX-002, 1g Canasa® and placebo suppository once daily in the DB phase. Participants who complete or discontinue the study at Week 6 will either receive 1g MAX-002 suppositories on a voluntary basis, standard care treatment as per investigator's discretion or no treatment during the next 8 weeks of the OL phase. Total duration of treatment will be of 14 weeks. Efficacy will primarily be evaluated by percentage of participants who show response as per Mayo DAI Score at Week 6. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants who are 18 years old or older
* Participants with total Mayo DAI score between 5 to 10 at Screening and participants with score of 2 or more for the rectal bleeding and for the findings of flexible proctosigmoidoscopy or colonoscopy sub-scores of the Mayo DAI
* Participants with confirmed mild to moderate active UP not extending above rectum as evidenced by flexible proctosigmoidoscopy and histopathology assessments
* Female participants of child-bearing age who have negative serum beta-human chorionic gonadotropin (β-HCG) at the time of entry into the study
* Female participants of child-bearing age who use medically acceptable form of birth control
* Participants who are smokers and non-smokers must not change their smoking habits or nicotine use during the DB treatment period
* Participants who are literate and have legal ability to sign informed consent form

Exclusion Criteria:

* Participants with other digestive diseases interfering with the measurement of any sub-score of the Mayo DAI
* Participants with 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
* Participants with clinically significant electrocardiographic abnormalities that would compromise its participation in the study
* Participants who are chronically using oral 5-aminosalicylic acid (5-ASA) at a dose greater than 4g 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
* Participants with significant use of corticosteroids ,immunosuppressant's or biologic response modifiers that may have a therapeutic effect on ulcerative proctitis during the 45 days before the date of consent
* Participants who use any rectally administered medicine during the 30 days prior to randomization
* Participants who have contraindication to the use of mesalamine or suppository vehicle, analgesia, flexible proctosigmoidoscopy or colonoscopy
* Participants who have blood parameters of grade 3 or higher on the common terminology criteria for adverse events (CTCAE) 5-point scale
* Participants with severe renal or hepatic impairment with parameters of grade 3 or higher on the CTCAE
* Participants with clinically significant urinary tract obstruction and history of idiopathic pancreatitis
* Participants with presence of other known clinically significant medical and/or psychological illnesses precluding participation
* Participants who participate in clinical studies other than observational studies during the 90 days before the date of the informed consent form signature
* Participants who are unable or unwilling to complete the follow-up evaluations required for the study

Primary outcomes:
measure: Percentage of Participants Who Were Responders at Week 6
timeFrame: Week 6
Secondary outcomes:
measure: Percentage of Participants Who Were Responders at Week 3
timeFrame: Week 3
measure: Time to Relief of Rectal Bleeding
timeFrame: Day 1 up to Week 6
measure: Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6
timeFrame: Baseline, Week 6
measure: Time to Relief of Tenesmus
timeFrame: Day 1 up to Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Gastroenterology Associates P.C.
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Tucson
country: United States
facility: Desert Sun Gastroenterology
state: Arizona
city: Thornton
country: United States
facility: Rocky Mountain Gastroenterology Associates
state: Colorado
city: Torrington
country: United States
facility: Litchfield County Gastroenterology and Associates
state: Connecticut
city: Boynton Beach
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Hollywood
country: United States
facility: Center for Gastrointestinal Disorders
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Newnan
country: United States
facility: Digestive Research Associates
state: Georgia
city: Evansville
country: United States
facility: Advanced Pain Care Clinic
state: Indiana
city: Jackson
country: United States
facility: Gastrointestinal Associates
state: Mississippi
city: Mexico
country: United States
facility: Center for Digestive & Liver Diseases Inc.
state: Missouri
city: Marlton
country: United States
facility: South Jersey Gastroenterology
state: New Jersey
city: Brooklyn
country: United States
facility: Synergy First Medical
state: New York
city: New York
country: United States
facility: Research Associates of New York (RANY)
state: New York
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Germantown
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Nashville
country: United States
facility: The First Clinic
state: Tennessee
city: Laredo
country: United States
facility: South Texas Research Alliance
state: Texas
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
city: Abbotsford
country: Canada
facility: Gastroenterology & Hepatology Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: Diamond Health Care Centre
state: British Columbia
city: Guelph
country: Canada
facility: Surrey GI Clinic Research
state: Ontario
city: Hamilton
country: Canada
facility: St-Joseph's Healthcare Hamilton
state: Ontario
city: Richmond Hill
country: Canada
facility: DHC Research
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates Inc. (TDDA)
state: Ontario
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Bialystok
country: Poland
facility: GASTROMED s.c.
city: Czestochowa
country: Poland
facility: Wojewódzki Szpital Specjalistyczny Oddz. Gastroenterologii
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny
city: Lublin
country: Poland
facility: Wojewodzki Szpital Specjalistyczny
city: Lublin
country: Poland
facility: SP Szpital Kliniczny
city: Pruszków
country: Poland
facility: Szpital Kolejowy
city: Rzeszow
country: Poland
facility: MEDICOR - Centrum Medyczne
city: Sopot
country: Poland
facility: Endoskopia SP. Z o.o.
city: Warszawa
country: Poland
facility: Gabinet Lekarski LECHMED
Study officials:
affiliation: Forest Laboratories
name: Aptalis Medical Information
role: STUDY_DIRECTOR
References: