Efficacy and Safety Study to Treat Subjects With Symptomatic Internal Hemorrhoids
- Conditions
- Internal Hemorrhoids
- Interventions
- Registration Number
- NCT01355874
- Lead Sponsor
- Ventrus Biosciences, Inc
- Brief Summary
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).
- Detailed Description
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. Safety Secondary Objective To determine the safety of iferanserin ointment administered intra-anally BID for 7 or 14 days in subjects with symptomatic internal hemorrhoids.
Exploratory Objectives:
To evaluate the frequency of recurrence of bleeding in subjects with symptomatic internal hemorrhoids. To evaluate time to bleeding recurrence in subjects with symptomatic internal hemorrhoids. To evaluate efficacy of iferanserin ointment in the treatment of recurrence when administered intra-anally BID for 7 days in subjects with symptomatic internal hemorrhoids. To evaluate the parameters of the Symptom Satisfaction Questionnaire
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.
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).
Secondary Endpoints:
Key Secondary Endpoints Cessation of itching by the end of Day 7 that persists for the remainder of the treatment period (through Day 14). Cessation of pain by the end of Day 7 that persists for the remainder of the treatment period (through Day 14). Safety Secondary Endpoints Adverse events (AEs). Serious Adverse events (SAEs). Physical examination. Hematology, serum chemistry, and urinalysis. Vital signs. Electrocardiogram.
Exploratory Endpoints:
Bleeding recurrence rate of symptomatic internal hemorrhoids. Time to bleeding recurrence of symptomatic internal hemorrhoids. Response to open-label iferanserin ointment in the treatment of recurrence of symptomatic internal hemorrhoids. Overall improvement score for the parameters of the Symptom Satisfaction Questionnaire.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 403
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Iferanserin + Placebo Iferanserin + Placebo - Iferanserin Iferanserin -
- Primary Outcome Measures
Name Time Method Proportion of subjects with cessation of bleeding by the end of Day 7 that persists for the remainder of the treatment period (through Day 14) will be analyzed as the primary endpoint 7 days
- Secondary Outcome Measures
Name Time Method Proportion of subjects with cessation of pain by the end of Day 7 that persists for the remainder of the treatment period (through Day 14). 7 days
Trial Locations
- Locations (76)
Central Sooner
🇺🇸Norman, Oklahoma, United States
MRA
🇺🇸Miami, Florida, United States
Clin Res Nevada
🇺🇸Las Vegas, Nevada, United States
Med Center for Clinical Research
🇺🇸San Diego, California, United States
Med Center
🇺🇸Carmichael, California, United States
South Orange County Surgical Group
🇺🇸Laguna Hills, California, United States
Facey Med Foundation
🇺🇸Mission Hills, California, United States
Ashville Gastro
🇺🇸Asheville, North Carolina, United States
Vital
🇺🇸Greenboro, North Carolina, United States
Trial Management Associates
🇺🇸Wilmington, North Carolina, United States
Hightop Med Res
🇺🇸Cincinnati, Ohio, United States
Eastern
🇺🇸Hilieah, Florida, United States
Colorado Research
🇺🇸Salida, Colorado, United States
Pinnacle Med Inst
🇺🇸Overland, Kansas, United States
First Clinic
🇺🇸Nashville, Tennessee, United States
Dial Research
🇺🇸Nashville, Tennessee, United States
Comprehensive Health Services
🇺🇸Phoenix, Arizona, United States
Adobe
🇺🇸Tucson, Arizona, United States
Digestive Health
🇺🇸Dothan, Alabama, United States
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
ACRI
🇺🇸Anaheim, California, United States
Aplusresearch
🇺🇸Miami, Florida, United States
Advanced Gastro Assoc
🇺🇸Palm Harbor, Florida, United States
Kentucy med Center
🇺🇸Lexington, Kentucky, United States
Dayton Gastro
🇺🇸Dayton, Ohio, United States
Clinsearch
🇺🇸Chattanooga, Tennessee, United States
Pioneer Research
🇺🇸Sugarland, Texas, United States
New River Valley Res
🇺🇸Christianburg, Virginia, United States
Desert Sun Clin Res
🇺🇸Tucson, Arizona, United States
AR Gastro
🇺🇸Sherwood, Arkansas, United States
Providence Clin Res
🇺🇸Burbank, California, United States
Torrence C. R.
🇺🇸Lomita, California, United States
Premiere Clin Res
🇺🇸Long Beach, California, United States
Community Clin Trials
🇺🇸Orange, California, United States
Futura Research
🇺🇸Montebello, California, United States
Del Carmen Med Center
🇺🇸Reseda, California, United States
MARG
🇺🇸San Diego, California, United States
Westlake Res
🇺🇸Westlake Village, California, United States
Innovative
🇺🇸Clearwater, Florida, United States
Avail Clin Res
🇺🇸DeLand, Florida, United States
Nature Coast Clin Res
🇺🇸Inverness, Florida, United States
Center for GI Disorders
🇺🇸Hollywood, Florida, United States
Jupiter Research
🇺🇸Jupiter, Florida, United States
Kendall
🇺🇸Miami, Florida, United States
Southeast REgional Research Group
🇺🇸Columbus, Georgia, United States
ICR
🇺🇸Sanford, Florida, United States
Tri County
🇺🇸Hartwell, Georgia, United States
Southeast Regional Research Group
🇺🇸Savannah, Georgia, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Praetorian Pharmaceutical Res
🇺🇸Marrerro, Louisiana, United States
Mid Atlantic Res Center
🇺🇸Hollywood, Maryland, United States
Clinical Trials Mgmt
🇺🇸Metarie, Louisiana, United States
Delta Research
🇺🇸Monroe, Louisiana, United States
Women Under Study
🇺🇸New Orleans, Louisiana, United States
Capital Digestive
🇺🇸Chevy Chase, Maryland, United States
Meritus Center for Clin Res
🇺🇸Hagerstown, Maryland, United States
Saginaw Med Res
🇺🇸Saginaw, Michigan, United States
Gastro Assoc Western Michigan
🇺🇸Wyoming, Michigan, United States
Center for Digestive & Liver Diseases
🇺🇸Mexico, Missouri, United States
Gastrointestinal Associates
🇺🇸Jackson, Mississippi, United States
Midwest Center for Clin Res
🇺🇸Lee's Summitt, Missouri, United States
Long Island GI Group
🇺🇸Great Neck, New York, United States
S. Jersey Gastro
🇺🇸Marlton, New Jersey, United States
MRA NY
🇺🇸New York, New York, United States
Carolinas Res Ass
🇺🇸Davidson, North Carolina, United States
Carolinas Research
🇺🇸Harrisburg, North Carolina, United States
Wake Res
🇺🇸Raleigh, North Carolina, United States
Great Lakes Gastro
🇺🇸Mentor, Ohio, United States
Houston Gastro
🇺🇸Houston, Texas, United States
Memphis Gastro
🇺🇸Germantown, Tennessee, United States
Texas Health Research
🇺🇸Fort Worth, Texas, United States
Assoc of Gastro
🇺🇸Hermitage, Tennessee, United States
Amcare Research
🇺🇸Houston, Texas, United States
Permian
🇺🇸Odessa, Texas, United States
ARI
🇺🇸Sandy, Utah, United States
Blue Ridge Medical Center
🇺🇸Lyncburg, Virginia, United States