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An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride

Information source: Ventrus Biosciences, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adult Subjects With Anal Fissures.

Intervention: Diltiazem Hydrochloride Cream and Oral Diltiazem (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Ventrus Biosciences, Inc


The study is a single-center, open-label, safety and pharmacokinetic study in12 adult subjects with Anal Fissures. Subjects will be screened to determine eligibility within 7 days of treatment. There will be three parts to the study and all subjects will participate in each part.

Clinical Details

Official title: An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Single and multiple dose Pharmacokinetic parameters

Secondary outcome: Safety as determined by nature, severity and relationship of adverse events, clinical labs, physical exam findings, vital signs and Electrocardiogram


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Subjects with evidence of a circumscribed anal fissure, with induration at the edges.

- Any female of non-childbearing potential 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 the screening visit).

- Any female of child bearing potential must 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 and freely willing to provide written informed consent prior to

participating in the study. Exclusion Criteria:

- Unwilling to have visual or medical examination of the Anal Fissure.

- More than 1 Anal Fissure.

- Subjects with Anal Fissure 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 Day - 1 through end of the study.

- Use of sitz bath from signing of ICF (Informed Consent Form) to end of study.

- 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.

- Active treatment with anti-viral therapies for HIV (e. g. indinavir,

nelfinivir,ritonavir). 10. Treatment with any prohibited medications within 14 days prior to signing the ICF:

- Cytochrome P450 (CYP450) inhibitors and inducers

- Cytochrome P3A4 (CYP3A4) substrates, inhibitors, and inducers

- Benzodiazepines

- β-adrenoceptor antagonists (Beta-Blockers)

- Calcium channel blockers

- Digoxin

- Investigational agents

- Opioids

- Following concomitant disease state:

- Sick sinus syndrome except in the presence of a functioning ventricular


- Second-or third-degree Atrioventricular block except in the presence of a

functioning ventricular pacemaker.

- Hypotension (less than 90 mm Hg systolic).

- Acute myocardial infarction and pulmonary congestion documented by x-ray.

- History of clinically significant renal disease.

- History of clinically significant Alzheimer's or Parkinson's disease.

- History of clinically significant hepatic disease.

- Current infection treated with a macrolide antibiotic.

- Clinical evidence or history of fecal incontinence.

- Clinical evidence or history of anal fistula.

- Clinical evidence or history of anal abscess.

- History of inflammatory bowel disease (e. g. Crohn's disease, Ulcerative


- History of any prior anal or rectal surgery including but not limited to:

lateral sphincterotomy and anal stretch.

- History of radiation therapy to the pelvis.

- Fixed anal stenosis/fibrosis.

- Major organ transplant.

- Any clinically significant laboratory abnormalities during screening.

- BMI > 40 kg/m2.

- Malignancy within 5 years prior to randomization (with the exception of treated basal

cell/squamous cell carcinoma of the skin).

- Any disease or prior/planned surgery that may interfere with the subject successfully

completing the study.

- Currently using narcotic(s) chronically.

- Breast-feeding females.

- Employees, family members, or students of the investigator or clinical site.

Locations and Contacts

Wake Research Associates, Raleigh, North Carolina, United States
Additional Information

Starting date: February 2013
Last updated: August 19, 2013

Page last updated: August 23, 2015

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