Efficacy and Safety Study to Treat Subjects With Symptomatic Internal Hemorrhoids
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Internal Hemorrhoids
In brief
Primary Objective: To evaluate the effect of iferanserin ointment on cessation of bleeding when administered intra-anally twice daily (BID) for 7 or 14 days in subjects with symptomatic internal hemorrhoids. Methodology: Double-Blind: Phase 3, multicenter, double-blind, randomized, parallel group, placebo-controlled part of the study. Extension: Multicenter, open-label part of the study. Study Treatment Duration: Double-Blind: 28 days (14-day treatment period and a 14-day follow-up period). Extension: 12 months (open-label part of the study in which there will be a scheduled visit every three months. Subjects who have recurrence(s) of their symptomatic internal hemorrhoids will be treated with open-label iferanserin for 7 days followed by a 21-day follow-up period). Criteria for Evaluation: Primary Endpoint: The primary endpoint is the cessation of bleeding by the end of Day 7 that persists for the remainder of the treatment period (through Day 14).
Key facts
- Study ID
- NCT01355874
- Run by
- Ventrus Biosciences, Inc
- People needed
- 403
- Starts
- 2011-07-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2014-01-28
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Clinical Research Associates — Huntsville, Alabama, United States
- Comprehensive Health Services — Phoenix, Arizona, United States
- Adobe — Tucson, Arizona, United States
- Desert Sun Clin Res — Tucson, Arizona, United States
- AR Gastro — Sherwood, Arkansas, United States
- ACRI — Anaheim, California, United States
- Providence Clin Res — Burbank, California, United States
- Med Center — Carmichael, California, United States
- South Orange County Surgical Group — Laguna Hills, California, United States
- Torrence C. R. — Lomita, California, United States
- Premiere Clin Res — Long Beach, California, United States
- Facey Med Foundation — Mission Hills, California, United States
- Futura Research — Montebello, California, United States
- Community Clin Trials — Orange, California, United States
- Del Carmen Med Center — Reseda, California, United States
- MARG — San Diego, California, United States
- Med Center for Clinical Research — San Diego, California, United States
- Westlake Res — Westlake Village, California, United States
- Colorado Research — Salida, Colorado, United States
- Innovative — Clearwater, Florida, United States
- Avail Clin Res — DeLand, Florida, United States
- Eastern — Hilieah, Florida, United States
- Center for GI Disorders — Hollywood, Florida, United States
- Nature Coast Clin Res — Inverness, Florida, United States
- Digestive Health — Dothan, Alabama, United States
Full record on ClinicalTrials.gov
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