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    Summary
    EudraCT Number:2004-001000-12
    Sponsor's Protocol Code Number:4975-2-005-2
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2004-10-18
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2004-001000-12
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase II,
    Exploratory Evaluation of a Single Dose of ALGRX 4975 in Subjects
    with Acute Lateral Epicondylitis
    A.4.1Sponsor's protocol code number4975-2-005-2
    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 SponsorAlgoRx Pharmaceuticals, Inc.
    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 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 Information not present in EudraCT
    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 nameALGRX 4975
    D.3.2Product code ALGRX 4975
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapsaicin, Ultra-purified
    D.3.9.1CAS number 404-86-4
    D.3.9.2Current sponsor codeALGRX 4975
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection*
    D.8.4Route of administration of the placeboOther use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Lateral Epicondylitis (tennis elbow)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level HLT
    E.1.2Classification code 10024032
    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 a single dose of ALGRX 4975 in subjects with recent onset of acute lateral epicondylitis.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and determine the duration of effect of a single dose of ALGRX 4975
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Subjects of either gender, aged 18 - 75 years.
    2. Subjects with acute lateral epicondylitis (LE) of less than 3 months’ duration (subjects with recurrent acute LE may be included) with the following characteristics:
     pain on palpation of the epicondyle and/or the common extensor mass
     pain on wrist pronation and dorsiflexion against resistance with the elbow in extension
     pain reproduced by static stretching of the pronated wrist in palmar flexion with the elbow in extension
     Normal anterior-posterior and lateral X-ray films of the elbow
    3. Subjects with a screening (Visit 1) and baseline (Visit 2) severity of pain on resisted wrist dorsiflexion score of moderate or greater intensity.
    4. Subjects who are lidocaine responsive, as confirmed by an injection of lidocaine to the most tender spot at the screening visit. Only subjects who are totally pain free 15 minutes after the injection of lidocaine (2.5 mL of 2% lidocaine) will be allowed to enter the study. If the patient remains pain free at the baseline visit, he/she will not be eligible to participate in the study.
    5. The subject has a systolic and diastolic blood pressure not greater than 140 and 95 mm Hg, respectively
    6. Subjects who have provided written informed consent which has been approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB).
    7. Female subjects of childbearing potential with a negative serum pregnancy test prior to entry into the study. Female subjects may be included without a negative serum pregnancy test if they are surgically sterile or at least 2 years post-menopausal.
    8. Ability to understand the requirements of the study, abide by the study restrictions and agree to return for the required assessments.
    E.4Principal exclusion criteria
    1. The subject has a clinically significant form of joint disease at the elbow, other than acute LE.
    2. Subjects with a history of elbow trauma in the last 2 years.
    3. Subjects who are undergoing physiotherapy treatment within the preceding 2 weeks, prior to Visit 1.
    4. Subjects with a history of rheumatoid, inflammatory, degenerative, polyarthritis, metabolic/crystal-induced or infectious arthritis, or carpal tunnel syndrome.
    5. Subjects who have received any systemic or local corticosteroids within the preceding 3 months, except nasal or inhaled steroids at  1000 g/day.
    6. The subject has a medical condition other then LE that requires the use of a pain medication (e.g., fibromyalgia, inflammatory arthritis, musculoskeletal or articular disorder or any congenital, direct traumatic, crystal-induced, metabolic, infectious or immune-related disorder).
    7. The subject has a medical condition that in the Investigator’s opinion could adversely impact their participation or safety, conduct of the study, or interfere with the pain assessments.
    8. The subject has active cutaneous infection, trauma, or clinically significant form of disease at the anticipated site of injection.
    9. The subject used an analgesic, other than aspirin for cardiovascular prophylaxis, during the washout period that could confound the analgesic response.
    10. Subjects with any neuromuscular disorder affecting the area, including radial or ulnar nerve entrapment, or tumor.
    11. Subjects in whom the use of lidocaine, capsaicin or paracetamol is contraindicated (e.g., significant history of allergic reactions or intolerance to these or related substances).
    12. The subject has a peripheral sensory or motor neuropathy involving the upper extremities.
    13. The subject is taking an antihypertensive agent, antidepressant, or anticonvulsant that has not been stable for at least 2 months.
    14. The subject is diabetic and has not been on a stable diabetic regimen for the past 2 months.
    15. Female subjects who are pregnant or lactating.
    16. Female subjects of childbearing potential who are not practicing an effective method of contraception.
    17. The subject has taken any investigational medication within 3 months prior to the first dose of study drug (Visit 2), or is scheduled to receive an investigational drug other than ALGRX 4975 while participating in the study.
    18. Subjects who have previously entered this study.
    19. The subject has a history of drug or alcohol abuse within the past 2 years.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the pain induced by resisted wrist dorsiflexion (0=no pain, 1=full movement possible but slight pain, 2=movement possible but moderate pain, 3=movement possible but marked pain, 4=pain prevents any degree of resisted movement) 4 weeks after treatment. Pain induced by wrist dorsiflexion at other timepoints will be a secondary endpoint.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) 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 No
    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.8.5The 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 Information not present in EudraCT
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 50
    F.4.2.2In the whole clinical trial 50
    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 Decision2004-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-29
    P. End of Trial
    P.End of Trial StatusOngoing
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