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    Summary
    EudraCT Number:2007-003797-25
    Sponsor's Protocol Code Number:VOPO-PE-201
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-20
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2007-003797-25
    A.3Full title of the trial
    A randomized, double-blind, multi-center, vehicle-controlled, parallel group study to evaluate the efficacy and safety of diclofenac diethylamine 2.32% gel applied once or twice daily in subjects with acute ankle sprain
    A.4.1Sponsor's protocol code numberVOPO-PE-201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Consumer Health SA
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameDiclofenac diethylamine 2.32% gel
    D.3.2Product code DDEA 2.32%
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNdiclofenac diethylamine
    D.3.9.2Current sponsor codeDDEA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number23.2
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboGel
    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
    acute ankle sprain
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10002549
    E.1.2Term Ankle sprain
    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 efficacy of DDEA 2.32% gel administered OD or BID for 4 days compared with vehicle/placebo for the treatment of acute ankle sprain
    E.2.2Secondary objectives of the trial
    to evaluate the efficacy of DDEA 2.32% gel administered OD or BID for 2 or 7 days compared with vehicle

    to evaluate the safety and tolerability of DDEA 2.32% gel administered OD and BID for 7 days compared with vehicle
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females aged 18 to 75 years.
    2. If Women of Child Bearing Potential (WOCBP), i.e., not > 1 year postmenopausal or surgically sterilized, agreement to maintain an effective method of contraception throughout the study.
    WOCBP include all women physiologically capable of becoming pregnant, unless they meet the following definition of post-menopausal:
     12 months of natural (spontaneous) amenorrhea,
     6 months of spontaneous amenorrhea with serum FSH levels > 40 IU/mL, or
     6 weeks post surgical bilateral oophorectomy with or without hysterectomy.
    WOCBP must use one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Acceptable methods of contraception may also include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study.
    WOCBP must have negative urine pregnancy tests at screening and baseline.
    3. Acute sprain of the lateral ankle, Grade I-II
    4. Injury within past 48 hours.
    5. No pain medication taken since the injury (RICE authorized prior to randomization) - pain medication taken prior to the injury must be washed out
    6. Assessment of POM ≥ 50 mm on a 100 mm VAS
    7. Satisfactory health as determined by the investigator based on medical history and physical examination.
    8. Explicit agreement to follow study procedures, in particular concerning study medication (twice daily), concomitant medication (no other painkillers), diary entries (daily), and study visits (availability at all dates).
    9. Voluntarily sign and date the ICF, approved by an IRB/IEC, prior to the conduct of any study specific procedures.
    E.4Principal exclusion criteria
    1. Grade III ankle sprain and/or any concurrent injury concerning the lower extremities that is painful at rest or on movement, or might affect the mobilization of the subject.
    2. Any pain medication taken since the injury or washout requirement for oral pain medication not respected. Stable dose of aspirin (≤ 162 mg) for non analgesic reasons for at least 30 days prior to the first dose of study medication are permitted to be continued for the duration of the study.
    3. Topical analgesic or anti inflammatory treatment in the area to be treated over the previous month.
    4. Grade I sprain of the same ankle during the past 3 months.
    5. Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails), of the same ankle or foot, during the past 6 months.
    6. Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
    7. Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
    8. Any skin lesion or wound in area to be treated.
    9. Intent to undergo surgery or concomitant physiotherapy (including, but not exclusive to, TENS, massage, and spinal manipulation) or any other kind of pain therapy throughout the course of the study.
    10. Pregnancy, nursing, or WOCBP not practicing effective contraceptive methods.
    11. History of allergy (cutaneous or systemic), hypersensitivity, or asthma to any of the following: diclofenac, paracetamol, aspirin, methylsalicylate, other NSAID or COXIB.
    12. Known intolerance (cutaneous or systemic) to any of the ingredients in the gel, such as oleyl alcohol, isopropyl alcohol, or propylene glycol.
    13. Any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation, including AST or ALT > 3, or BUN > 1.5 times the upper limit of the reference range, or creatinine > 1.5 mg/dL.
    14. Any known active malignancy. A history of malignancy which was successfully treated, without evidence of recurrence, is acceptable.
    15. Chronic or acute renal or hepatic disorder, inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis), or a significant coagulation defect.
    16. History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening.
    17. History of uncontrolled chronic or acute concomitant disease which, in the investigator’s opinion, would contraindicate study participation or confound interpretation of the results.
    18. Pending worker’s compensation claim, litigation, or any other monetary settlement claim.
    19. Uncontrolled psychiatric disease or history of known narcotic, analgesic, or alcohol abuse.
    20. Positive urine pregnancy test.
    21. Positive urine drug screen test.
    22. Previous participation in this clinical study.
    23. Participation in any other clinical study within 30 days of the screening visit.
    24. Any physical impairment that would influence the study's efficacy evaluations, in particular POM and the Ankle Joint Function, such as: peripheral or central neurological disease, significant back pain, symptomatic osteoarthritis of the hips, knees, or feet, or any painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart).
    25. Any cognitive impairment that would, in the opinion of the investigator, preclude study participation or compliance with study procedures (e.g., Alzheimer's dementia).
    26. Likely to be non compliant with study producedures.
    E.5 End points
    E.5.1Primary end point(s)
    Pain-on-movement on VAS at Day 5
    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 Yes
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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 concerned20
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state270
    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 Decision2007-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-26
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