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    Summary
    EudraCT Number:2010-022794-34
    Sponsor's Protocol Code Number:862-P-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:2010-12-22
    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 number2010-022794-34
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multi-center parallel group phase IV study to evaluate the efficacy and safety of Voltaren® Schmerzgel 1.16% gel in subjects with acute neck pain
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the safety and effects of Voltaren Schmerzgel 1.16% on people with acute neck pain.
    A.4.1Sponsor's protocol code number862-P-201
    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 SponsorNovartis Consumer Health
    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 supportNovartis Consumer Health
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCRM Pharmaberatung GmbH
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street AddressMarie-Curie-Str. 2
    B.5.3.2Town/ cityRheinbach
    B.5.3.3Post code53359
    B.5.3.4CountryGermany
    B.5.4Telephone number00492226909840
    B.5.5Fax number004922269098499
    B.5.6E-mailinfo@crm-pharmaberatung.de
    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 Yes
    D.2.1.1.1Trade name Voltaren® Schmerzgel 1.16% Gel
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Consumer Health GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Gel
    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 INNDiclofenac
    D.3.9.1CAS number 15307-86-5
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.16
    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 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 neck pain, present for at least 12 hours.
    An acute condition is defined as pain shorter than 3 months [CPMP, 2002].
    Neck pain is defined as stiffness and/or pain felt dorsally in the cervical region somewhere between the occipital condyles and the C7 vertebral prominence [Ferrari 2003]. Only subjects with pain generated in the neck originating from cervical joints and accompanying soft tissue will be included.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10028836
    E.1.2Term Neck pain
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To show superior efficacy of Voltaren® Schmerzgel 1.16% gel versus placebo in the treatment of acute neck pain under 'in-use' conditions, as measured by POM at Visit 4.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of Voltaren® Schmerzgel 1.16% gel at each Visit time.
    To assess the safety of Voltaren® Schmerzgel 1.16% gel for 5 (+1) days under 'in-use' conditions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects, age range 18 and over.
    2. Acute neck pain, present for at least 12 hours.
    An acute condition is defined as pain shorter than 3 months [CPMP, 2002].
    Neck pain is defined as stiffness and/or pain felt dorsally in the cervical region somewhere between the occipital condyles and the C7 vertebral prominence [Ferrari 2003]. Only subjects with pain generated in the neck originating from cervical joints and accompanying soft tissue will be included.
    3. Pain-on-movement (POM) ≥ 50 mm on a 100 mm VAS.
    4. Satisfactory health as determined by the investigator based on medical history and physical examination.
    5. Subjects must understand and provide written informed consent before any assessment is performed, understand the study procedures, and be willing to complete the required assessments.
    E.4Principal exclusion criteria
    1. Current asthma, hay fever, swelling of the nasal mucosa or chronic obstructive respiratory tract diseases.
    2. History of or known hypersensitivity to any of the study drugs, excipients or to drugs of similar chemical classes. History of allergy (cutaneous or systemic), hypersensitivity, or asthma to any of the following: diclofenac, paracetamol, acetylsalicylic acid, salicylic acid, other NSAID or cyclooxygenase 2-specific inhibitor (COXIB) or known hypersensitivity (cutaneous or systemic) to any of the ingredients in the gel, such as propylene glycol and/or 2-propanol
    3. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
    · Surgical sterilization
    · Hormonal contraception
    · IUD
    · Double barrier method
    · Total abstinence throughout the study at the discretion of the Investigator.
    Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the study.
    A woman who is post-menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child bearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.
    4. Pregnant or nursing (lactating) women.
    5. Pain medication taken within the 6 hours that precede randomization. Chronic intake of small doses of acetylsalicylic acid (≤ 162 mg/daily) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued for the duration of the study.
    6. Concomitant use of any anti-inflammatory drugs, heparinoids or analgesics including herbal preparations (glucocorticosteroids, NSAIDs, etc.) for the same indication or other indications (e.g. rheumatoid arthritis).
    7. Any other concomitant treatment (e.g. cosmetics, ointments at the treated area) or medication that interferes with the conduct of the trial.
    8. History of active or suspected oesophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening.
    9. History of clinically significant cardiovascular, cerebrovascular, metabolic, pulmonary, neurological, haematological, autoimmune, psychiatric or endocrine disorders, including individuals with Type I or Type II diabetes.
    10. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
    11. Chronic or acute renal or hepatic disorder, inflammatory bowel disease (e.g. Crohn´s disease or ulcerative colitis), or a significant coagulation defect.
    12. Subject affected by rheumatoid arthritis or gout.
    13. History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results.
    14. Any neck pain that is attributable to an organic disease, such as prolapsed disc, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumors.
    15. Any recent strains of the neck muscles documented by the clinical evaluation and anamnesis.
    16. Chronic neck pain as defined as pain for 3 months or longer.
    17. Any skin lesions, or wound or infection in the area to be treated.
    18. Likelihood of prolapsed spinal disc documented by clinical symptoms (pain radiation to peripheral areas, paraesthesia, clinically detectable impairment of muscle strength of related areas).
    19. Risk factors for spinal infection.
    20. Uncontrolled psychiatric disease or history of known narcotic, analgesic, or alcohol abuse.
    21. Any cognitive impairment that would, in the opinion of the investigator, preclude study participation or compliance with the study procedures (e.g. Alzheimer´s dementia).
    22. Participation in any other clinical study within 30 days prior to the screening or 10 half-lives of enrollment, whichever is longer.
    23. Previous participation in this clinical study.
    24. Subjects directly or indirectly involved in the execution of this protocol, including employees of the CRO and persons related
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome is pain-on-movement measured on the VAS at Visit 4.
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned3
    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 No
    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
    See Protocol 6.5.8, p.20 and 6.5.10, p.21
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 72
    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.1.3Elderly (>=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 state72
    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 Decision2011-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-18
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