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
Overview
- Phase
- Phase 3
- Intervention
- MAX-002
- Conditions
- Proctitis, Ulcerative
- Sponsor
- Forest Laboratories
- Enrollment
- 119
- Locations
- 39
- Primary Endpoint
- Percentage of Participants Who Were Responders at Week 6
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Arms & Interventions
MAX-002
Intervention: MAX-002
Placebo
Intervention: Placebo
Canasa®
Intervention: Canasa®
Outcomes
Primary Outcomes
Percentage of Participants Who Were Responders at Week 6
Time Frame: Week 6
Participants were considered as responders if they had total Mayo Disease Activity Index (DAI) score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).
Secondary Outcomes
- Time to Relief of Rectal Bleeding(Day 1 up to Week 6)
- Time to Relief of Tenesmus(Day 1 up to Week 6)
- Percentage of Participants Who Were Responders at Week 3(Week 3)
- Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6(Baseline, Week 6)