Efficacy and Safety Study With Diltiazem Hydrochloride Cream to Treat Anal Fissures
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|ClinicalTrials.gov Identifier: NCT01690221|
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : January 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Anal Fissures||Drug: VEN 307 Drug: Placebo||Phase 3|
To evaluate the efficacy of diltiazem hydrochloride cream on reduction of worst anal fissure (AF)-related pain associated with or following defecation when administered three times a day (TID) for 28 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||434 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Topical Diltiazem Hydrochloride 2% Cream in Subjects With Anal Fissure|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2014|
Experimental: VEN 307
diltiazem hydrochloride 2% cream
Drug: VEN 307
VEN307 applied three times a day, in and around the anus, for 28 days.
Other Name: diltiazem hydrochloride 2% cream
Placebo Comparator: Placebo
Placebo cream applied three times a day, in and around the anus, for 28 days.
Other Name: Placebo cream
- Change from baseline (average NRS during the last 3 days in which subject had a defecation during the 7 day screening period) in average of worst AF-related pain associated with or following defecation for Days 22-28 (Week 4). [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690221
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