Adult Subjects With Anal Fissures.Phase 1NCT01816191
An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride
A Phase 1 study testing Diltiazem Hydrochloride Cream and Oral Diltiazem in people with Adult Subjects With Anal Fissures., run by Ventrus Biosciences, Inc at 1 site in United States.
Trial 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 will be three parts to the study and all subjects will participate in each part. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adult Subjects With Anal Fissures.
- What is being tested?
- Diltiazem Hydrochloride Cream and Oral Diltiazem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with evidence of a circumscribed anal fissure, with induration at the edges.
- Any female of non-childbearing potential who:
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Adult Subjects With Anal Fissures.
- Being tested
- Diltiazem Hydrochloride Cream and Oral Diltiazem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diltiazem Hydrochloride Cream and Oral DiltiazemDrug
| Study group | Role | What they receive |
|---|---|---|
| Diltiazem Hydrochloride | Experimental | Topical cream and oral pill Receives: Drug: Diltiazem Hydrochloride Cream and Oral Diltiazem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single and multiple dose Pharmacokinetic parameters
Single- and multiple-dose PK parameters for topical DTZ and single-dose PK parameters for oral DTZ including AUC(0-t), AUC(0-∞), Cmax, tmax, t1/2 and CL/F. PK parameters for DTZ, and its two metabolites (N-desmethylditiazem and O-desacetyldiltiazem) will be presented in Data Listings and summarized by Day (Study Day 1, 7 and 14). Descriptive statistics will include n, mean, SD, %CV, geometric mean,median, minimum, and maximum.
Measured: up to 6 months after enrollment begins
Secondary outcomes (1)
Safety as determined by nature, severity and relationship of adverse events, clinical labs, physical exam findings, vital signs and Electrocardiogram
Adverse events, physical examination findings, vital sign measurements, ECG results, and clinical laboratory data will be reviewed and summarized to evaluate the safety profile of topical DTZ cream and oral DTZ. Safety data will be summarized by study time point, and by change from Baseline using descriptive statistics as appropriate. Data listings will also be provided.
Measured: Up to 6 months after enrollment begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Subjects With Anal Fissures.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ventrus Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816191
- Sponsor's protocol ID
- VEN307-PK-001
- Status last verified
- Jul 2013
- First submitted
- 13 Mar 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride
- ClinicalTrials.gov ID
- NCT01816191
- Acronym / sponsor ID
- VEN307-PK-001
- Conditions
- Adult Subjects With Anal Fissures.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ventrus Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (estimated)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diltiazem Hydrochloride | Experimental | Drug: Diltiazem Hydrochloride Cream and Oral DiltiazemTopical cream and oral pill |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with evidence of a circumscribed anal fissure, with induration at the edges.
- Any female of non-childbearing potential who:
- 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.
Key exclusion criteria (42 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diltiazem Hydrochloride Cream and Oral Diltiazem | Drug | Diltiazem Hydrochloride |
Primary outcome
Single and multiple dose Pharmacokinetic parameters
Time frame: up to 6 months after enrollment begins
Single- and multiple-dose PK parameters for topical DTZ and single-dose PK parameters for oral DTZ including AUC(0-t), AUC(0-∞), Cmax, tmax, t1/2 and CL/F. PK parameters for DTZ, and its two metabolites (N-desmethylditiazem and O-desacetyldiltiazem) will be presented in Data Listings and summarized by Day (Study Day 1, 7 and 14). Descriptive statistics will include n, mean, SD, %CV, geometric mean,median, minimum, and maximum.
1 secondary outcome
Safety as determined by nature, severity and relationship of adverse events, clinical labs, physical exam findings, vital signs and Electrocardiogram
Time frame: Up to 6 months after enrollment begins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diltiazem Hydrochloride Cream and Oral Diltiazem in people with Adult Subjects With Anal Fissures., run by Ventrus Biosciences, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single and multiple dose Pharmacokinetic parameters (time frame: up to 6 months after enrollment begins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2013.