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    Summary
    EudraCT Number:2012-003753-28
    Sponsor's Protocol Code Number:VEN307-AF-001
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2012-003753-28
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to examine how effective and safe Diltiazem cream is for patients who have an anal fissure.
    A.4.1Sponsor's protocol code numberVEN307-AF-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01690221
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVentrus Biosciences
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVentrus Biosciences
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVentrus Biosciences
    B.5.2Functional name of contact pointMonil Shah
    B.5.3 Address:
    B.5.3.1Street Address99 Hudson Street, 5th Floor
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10013
    B.5.3.4CountryUnited States
    B.5.6E-mailmshah@ventrusbio.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDiltiazem Cream
    D.3.2Product code VEN307
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDiltiazem Hydrochloride
    D.3.9.2Current sponsor codeVEN307
    D.3.9.3Other descriptive nameDILTIAZEM HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB13602MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain associated with anal fissures
    E.1.1.1Medical condition in easily understood language
    Pain associated with anal fissures
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect 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.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of diltiazem hydrochloride cream on reduction of overall daily AF-related pain when administered TID for 28 days.
    To evaluate PGI-I at Day 29 in subjects with AF-related pain.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females, aged ≥ 18 to ≤ 75 years.
    2. Subjects with evidence of a circumscribed fissure, with induration at the edges.
    3. Subjects with AF-related pain associated with or following defecation occurring > 2 times a week for > 28 days prior to signing the informed consent form (ICF).
    4. AF-related pain associated with or following defecation > 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).
    5. Average AF-related pain associated with or following defecation > 5 on an 11-point NRS during the last 3 days in which subject had a defecation during the 7 days prior to randomization (Day 1) (subject must call in to the IVRS at least 5 of 7 days during screening).
    6. 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 the screening visit).
    7. 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.
    8. Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
    9. Capable of using the IVRS and able to adequately communicate comprehension of the IVRS questions to the investigator.
    10. Capable of and freely willing to provide written informed consent prior to participating in the study.
    E.4Principal exclusion criteria
    1. Unwilling to have visual or medical examination of the AF.
    2. More than 1 AF.
    3. 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.
    4. Unwilling to stop all other concomitant topical preparations applied in and around the anus from signing of ICF through Day 29 of the study.
    5. Use of glyceryl trinitrate (GTN) ointment > 7 days (continuous or not) in the 28 days prior to signing the ICF.
    6. 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.
    7. Unwilling to discontinue use of anesthetics from signing the ICF to end of study.
    8. Subfissure injection of botulinum toxin in the 3 months prior to signing the ICF.
    9. Known sensitivity to investigational product(s) or calcium channel blockers.
    10. Previous treatment with diltiazem hydrochloride cream or any other topical calcium channel blockers.
    11. Active treatment with anti-viral therapies for HIV (e.g. indinavir, nelfinivir, ritonavir).
    12. 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
     Quinidine
     Rifampin
    13. Following concomitant disease state:
     Sick sinus syndrome except in the presence of a functioning ventricular
    pacemaker.
     Second-or third-degree AV 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 bipolar disorder, psychosis, schizophrenia, mania, suicide attempt or suicidal ideation, or any other significant psychiatric illness (with the exception of intermittent anxiety) per investigator judgment.
     History of clinically significant renal disease per investigator
    judgment.
     History of clinically significant Alzheimer’s or Parkinson’s disease per
    investigator judgment.
     History of clinically significant hepatic disease per investigator
    judgment.
     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 (with the exception of hemorrhoidal banding and laser surgery).
     Grade 4 hemorrhoids.
    Chronic constipation.
    14. History of radiation therapy to the pelvis.
    15. Fixed anal stenosis/fibrosis.
    16. Major organ transplant.
    17. Any clinically significant laboratory abnormalities during screening per investigator judgment.
    18. BMI > 40 kg/m2 (http://www.nhlbisupport.com/bmi/bmicalc.htm).
    19. Malignancy within 5 years prior to randomization (with the exception of treated basal cell/squamous cell carcinoma of the skin).
    20. Any disease or prior/planned surgery that may interfere with the subject successfully completing the study.
    21. Currently using narcotic(s).
    22. Breast-feeding females.
    23. Employees, family members, or students of the investigator or clinical site.
    E.5 End points
    E.5.1Primary end point(s)
    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).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 22-28 after Baseline.
    E.5.2Secondary end point(s)
    Change from baseline (average NRS during the 7 day screening period) in average of overall AF-related pain for Days 22-28 (Week 4).
    PGI-I values assessed at Day 29 visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 22-28 after Baseline, and on Day 29 after Baseline, respectively.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Canada
    Israel
    Poland
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 400
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-20
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