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NCT01016262 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
A Phase 3 study, sponsored by Forest Laboratories.
- Terminated
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
NCT01016262: Clinical Trial Phase 3 study, sponsored by Forest Laboratories.
NCT01016262 is a Phase 3 study that was terminated before completion, run by Forest Laboratories. The registered enrollment target is 119 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01016262, a Phase 3 study, was terminated before completion, sponsored by Forest Laboratories.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
Study 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).
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG MAX-002
- DRUG Canasa®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2009-11-30 |
| Est. Completion | 2011-09-30 |
| Phase | Phase 3 |
Why NCT01016262 stopped before completion
NCT01016262 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01016262 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01016262 about?
NCT01016262 is a clinical study titled "Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis". 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 ...
What is the current status of trial NCT01016262?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2009-11-30. Estimated completion is 2011-09-30.
What interventions are being tested in trial NCT01016262?
The interventions under investigation include: Placebo (DRUG), MAX-002 (DRUG), Canasa® (DRUG).
Who is sponsoring clinical trial NCT01016262?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01016262's enrollment target sits among peer trials
119 1640th of 2000 higher than 360 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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