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    Summary
    EudraCT Number:2008-008721-29
    Sponsor's Protocol Code Number:KYT62121/2008-01
    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:2009-05-11
    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 number2008-008721-29
    A.3Full title of the trial
    Double-blind, randomised, multi-centre, placebo-controlled clinical trail to investigate the efficacy and safety of a combination of comfrey root extract plus methyl nicotinate versus a preparation containing methyl nicotinate alone or placebo in patients with conditions of acute upper or low back pain.
    A.3.2Name or abbreviated title of the trial where available
    COIL2
    A.4.1Sponsor's protocol code numberKYT62121/2008-01
    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 SponsorMerck Selbstmedikation GmbH
    B.1.3.4CountryGermany
    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 Yes
    D.2.1.1.1Trade name Kytta-Balsam f
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Selbstmedikation 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 Cream
    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.3.9.3Other descriptive namecomfrey root extract
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.3Concentration number35
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 93-60-7
    D.3.9.3Other descriptive nameMethylnikotinat
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.3Concentration number1.2
    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 Yes
    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 Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 nameMethylnikotinat
    D.3.4Pharmaceutical form Cream
    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.3.9.1CAS number 93-60-7
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.3Concentration number1.2
    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 Information not present in EudraCT
    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
    Acute upper or low back pain as described in the note for guidance on clinical investigation of medical products for treatment of Nociceptive Pain (CPMP/EWP/612/00. Nov. 21, 2002)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000683
    E.1.2Term Acute back pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to show that Kytta-Balsam® f (a combination of comfrey root extract plus methyl nicotinate) is superior to the single preparation of methyl nicotinate or placebo cream as assessed by time-specific pain intensity difference in the indication of acute upper or low back pain. The primary efficacy variable is the area-under-the-curve (AUC) of the Visual Analogue Scale (VAS) on active standardised movement values at Visits 1 to 4 (at actual measurement times).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are: · Back pain at rest, assessment by patient on Visual Analogue Scale (VAS). Rationale: besides pain of active motion VAS at rest is another alternative to measure Nociceptive Pain in back pain. · Pressure algometry (pain-time curve; AUC over 5 days). Rationale: algometric pain measurement is a relevant and highly sensitive surrogate parameter for the assessment of pain, which has been used in the identification of trigger points and evaluation of pain sensitivity . Because of its reliability and reproducibility algometry is used in objective medico-legal documentation of pain intensity. · Global assessment of efficacy by patient. · Global assessment of efficacy by the investigator. · Consumption of rescue medication. Rationale: consumption of analgesics is an indirect parameter for the efficacy of the treatment. · Functional impairment measured with the Oswestry Disability Index.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age range 18-45 years.
    2. Good general condition.
    3. Written informed consent.
    4. Acute back pain (either upper or low back pain), not in combination.
    5. Sensitivity to algometric pressure on the site contralateral to the painful trigger point at least 2.5 N/cm².
    6. Back pain on active standardised movement of at least 50 mm on a 100 mm Visual Analogue Scale, (VAS).
    7. Basic value of the pressure algometry on the trigger point shall not exceed 50% of the respective value of the site contralateral to the painful trigger point.
    E.4Principal exclusion criteria
    1. Upper or low back pain that is attributable to any identifiable cause (e. g. disc prolapse, spondylolisthesis, osteomalacia, or inflammatory arthritis).
    2. Any recent trauma.
    3. Any recent strains of the back muscles documented by the clinical evaluation and anamnesis.
    4. Chronic back pain.
    5. Likelihood of prolapsed spinal disc documented by clinical symptoms (pain irradiation to peripheral areas, paraesthesia, clinically detectable impairment of muscle strength of related areas).
    6. Back pain caused by metabolic or neurological diseases documented by anamnesis (i.e. toxic neuropathy).
    7. Diabetes Mellitus.
    8. Risk factors for spinal infection.
    9. Recent onset of bladder dysfunction or severe or progressive neurological deficit in the low extremity (as a possible indication of prolapsed disk).
    10. 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).
    11. Analgesics or NSAIDs applied by any route of administration within 10 days of study entry or corticoid drugs applied by any route of administration within 60 days of study entry.
    12. Any other concomitant treatment or medication that interferes with the conduct of the trial.
    13. Known intolerance or hypersensitivity (allergy) to comfrey extract, peanut, soya, methyl nicotinate, parabenes or one of the other ingredients of the trial treatments, including known toxic reactions.
    14. Local skin affections that do not allow the application of the test cream.
    15. Participation in a clinical trial within the previous 30 days before enrolment in the trial, participation in this study before or simultaneous participation in another clinical trial.
    16. Pregnancy or lactation period.
    17. Women with childbearing potential without an effective contraceptive method.
    18. Abuse of alcohol, medicaments or illicit drugs.
    19. Any patient in the investigator’s opinion not considered suitable for enrolment.
    20. Legal incapacity or limited legal capacity to give informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the area-under-the-curve (AUC) of the Visual Analogue Scale (VAS) on active standardised movement values at Visits 1 to 4 (at actual measurement times).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Yes
    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 concerned6
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=65 years) No
    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 state378
    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 Decision2009-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-04
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