Efficacy and Safety Study With Diltiazem Hydrochloride Cream to Treat Anal Fissures

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Anal Fissures

In brief

The purpose of this study is to determine if the study drug, VEN307 (diltiazem hydrochloride cream) is safe and to see if it will help with treatment of pain associated with anal fissures.

Key facts

Study ID

NCT01690221

Run by

Ventrus Biosciences, Inc

People needed

434

Starts

2012-10-01

Expected to finish

2014-01-01

Last updated by the study team

2014-01-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females, aged ≥ 18 to ≤ 75 years.
• Subjects with evidence of a circumscribed fissure, with induration at the edges.
• Subjects with AF-related pain associated with or following defecation occurring at least 2 times a week for at least 28 days prior to signing the informed consent form (ICF).
• AF-related pain associated with or following defecation of at least 5 on an 11-point numerical rating score scale (NRS) at the last defecation prior to signing the ICF (0 being no pain; 10 being the worst possible pain).
• Average AF-related pain associated with or following defecation of at least 5 on an 11-point NRS during the last 3 days in which subject had a defecation during the 7 days prior to randomization.
• Any female of non-childbearing potential, including any female who: a) has had a hysterectomy, b) has had a bilateral oophorectomy, c) has had a bilateral tubal ligation or d) is post menopausal (demonstration of total cessation of menses for ≥ 1 year from the date of screening visit).
• Females of child bearing potential who agree to use at least one form of contraception (may be a barrier method), during the full duration of the study.
• Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
• Capable of using the IVRS and able to adequately communicate comprehension of the IVRS questions to the investigator.
• Capable of and freely willing to provide written informed consent prior to participating in the study.

You may not qualify if…

• Unwilling to have visual or medical examination of the AF.
• More than 1 AF.
• Subjects with AF associated with or caused by other conditions, including but not limited to: drug-induced, trauma, HIV infection, fistula-in-ano, inflammatory bowel disease, perianal sepsis or malignancy.
• Unwilling to stop all other concomitant topical preparations applied in and around the anus from signing of ICF through Day 29 of the study.
• Use of glyceryl trinitrate (GTN) ointment for 7 days (continuous or not) in the 28 days prior to signing the ICF.
• Unwilling to discontinue use of sitz baths for up to 4 hours after each application of investigational product from signing of ICF to end of study.
• Unwilling to discontinue use of anesthetics from signing the ICF to end of study.
• Subfissure injection of botulinum toxin in the 3 months prior to signing the ICF.
• Known sensitivity to investigational product(s) or calcium channel blockers.
• Previous treatment with diltiazem hydrochloride cream or any other topical calcium channel blockers.
• Active treatment with anti-viral therapies for HIV (e.g. indinavir, nelfinivir, ritonavir).
• Treatment with any of the following medications within 14 days prior to signing the ICF:
• Amitriptyline
• Benzodiazepines
• β-adrenoceptor antagonists (Beta-Blockers)
• Buspirone
• Calcium channel blockers
• Carbamazepine
• Cimetidine
• Cyclosporin
• Digoxin
• Investigational agents
• Lovastatin
• Opioids
• Pregabalin

Where it is running

• Surgical Association of Mobile — Mobile, Alabama, United States
• University of South Alabama — Mobile, Alabama, United States
• Montgomery Women's Health Association, PC — Montgomery, Alabama, United States
• Mayo Clinic - Arizona — Phoenix, Arizona, United States
• Desert Sun Clinical Research, LLC — Tucson, Arizona, United States
• Arrowhead Regional Medical Center — Colton, California, United States
• UC San Diego — La Jolla, California, United States
• Alliance Research Centers — Laguna Hills, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Cedars Sinai — Los Angeles, California, United States
• Gastrointestinal Biosciences — Los Angeles, California, United States
• University of California - Irvine Medical Center — Orange, California, United States
• Digestive Care Associated, A Medical Corporation — San Carlos, California, United States
• West Coast Clinical Research — Tarzana, California, United States
• Rocky Mountain Clinical Research, LLC — Denver, Colorado, United States
• Colorado Research Works — Pueblo, Colorado, United States
• Rocky Mountain Clinical Research, LLC — Thornton, Colorado, United States
• Connecticut Clinical Research Foundation CT Gastroenterology Institute At Bristol Hospital — Bristol, Connecticut, United States
• Washington Hospital Center - MedStar Health Research Institute — Washington D.C., District of Columbia, United States
• Innovative Medical Research of South Florida — Aventura, Florida, United States
• South Lake Pain Institute — Clermont, Florida, United States
• Private Practice — Hollywood, Florida, United States
• Advance Medical Research Center — Miami, Florida, United States
• Well Pharma Medical Research Corp. — Miami, Florida, United States
• The Crawford Clinic — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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