Status:
UNKNOWN
An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride
Lead Sponsor:
Ventrus Biosciences, Inc
Conditions:
Adult Subjects With Anal Fissures.
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 pacemaker.
- 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 Colitis).
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01816191
Start Date
February 1 2013
End Date
September 1 2013
Last Update
August 21 2013
Active Locations (1)
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1
Wake Research Associates
Raleigh, North Carolina, United States