Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-000078-21
    Sponsor's Protocol Code Number:HCT 3012-X-303
    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:2007-07-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-000078-21
    A.3Full title of the trial
    A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo bid and Naproxen 500 mg bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT 3012) 750 mg bid, in Patients with Osteoarthritis of the Hip
    A.4.1Sponsor's protocol code numberHCT 3012-X-303
    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 SponsorNicOx S.A
    B.1.3.4CountryFrance
    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 nameNaproxcinod capsules
    D.3.2Product code HCT 3012
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaproxcinod
    D.3.9.1CAS number 163133-43-5
    D.3.9.2Current sponsor codeHCT 3012
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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.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 Yes
    D.2.1.1.1Trade name Naproxen
    D.2.1.1.2Name of the Marketing Authorisation holderWest ward Pharmaceuticals Corp
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameNaproxen
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaproxen
    D.3.9.1CAS number 22204-53-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteoarthritis of the Hip
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020108
    E.1.2Term Hips osteoarthritis
    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 study is to demonstrate that naproxcinod 750 mg bid is superior to placebo bid in relieving OA signs and symptoms in patients with OA of the hip.
    E.2.2Secondary objectives of the trial
    1)To evaluate the effect on BP of naproxcinod 750 mg bid, vs. placebo bid and naproxen 500 mg bid, as measured by Office Blood Pressure Monitoring (OBPM) in patients with hip OA.

    2)To evaluate the general safety and tolerability of naproxcinod 750 mg bid vs. placebo bid and naproxen 500 mg bid.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Men and women >/= 40 years old.
    2) Patients must have felt hip pain consistent with OA pain for at least 3 months before the Screening Visit.
    3) Patients diagnosed with primary OA of the hip confirmed by the presence of undoubtful osteophyte(s) in the target hip in radiographs .
    4) The target joint (hip) must be the patient's primary source of OA pain.
    5) Global functional status Class I, II, or III (excluding IV) at the ACR classification.
    6) Current chronic user of NSAIDs or acetaminophen/paracetamol for their OA pain and anticipated to benefit from continuous treatment with NSAIDs .
    7) Must discontinue all analgesic and/or anti-inflammatory therapies at the Screening Visit except the study-specific rescue medication .
    8) Must experience a flare of pain at the Baseline Visit, following discontinuation of prior NSAID/analgesic therapy. The flare of pain is defined as:
    • WOMAC™ question #1 of pain subscale >/= 50 mm,
    and
    • Increase by >/= 15 mm as compared to the Screening Visit.
    9) Female patients must be post-menopausal (defined as at least 12 months post cessation of menses), surgically sterile or, if of childbearing potential, using a reliable method of contraception for at least 3 months prior to visit 1 (Screening Visit) and during the study. In addition, female patients must not be lactating.
    10) If of childbearing potential, female patients must have a negative urine pregnancy test at both Screening and Baseline Visits.
    11) Must be able to understand and comply with study requirements (e.g. attend morning clinic visit).
    12) Must provide a written, dated and signed Informed Consent (IC) prior to any study procedures.
    E.4Principal exclusion criteria
    1) Uncontrolled hypertension at Screening or Baseline Visits, as judged by the Investigator
    2) Uncontrolled diabetes at Screening or Baseline Visits, as judged by the Investigator.
    3) Hepatic impairment (alanine aminotransferase or aspartate aminotransferase > 2 times the Upper Limit of Normal) at the Screening blood collection.
    4) History of renal impairment and/or a serum creatinine value > 176 micromol/L (2.0 mg/dl) at the Screening blood collection.
    5) Clinically relevant abnormal electrocardiogram (ECG) (12-lead) at the Screening Visit, as judged by the Investigator.
    6) Diagnosis of gastric or duodenal ulceration and/or history of significant gastro duodenal bleeding
    7) History of hypersensitivity reactions (such as asthma, rhinitis, or urticaria) to aspirin, naproxen or any other NSAIDs; or hypersensitivity or contraindications to organic nitrate drugs or to acetaminophen/paracetamol at the Screening Visit.
    8) Low back pain which may interfere with the evaluation of the hip OA pain, as judged by the Investigator.
    9) Current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy, including but not limited to: rheumatoid arthritis, septic arthritis, systemic lupus erythematosus, spondyloarthropathy, Paget’s disease affecting the study joint, osteochondritis dessicans or osteonecrosis of the study joint, primary osteochondromatosis, Wilson’s disease, gout and fibromyalgia (to be discussed case per case), acromegaly, hemochromatosis, ochronotic arthritis, heritable disorders (e.g. hypermobility, collagen gene mutations, and articular fracture.
    10) Patients who are candidates for any imminent joint replacement that could occur during the study.
    11) History of any clinically relevant gastrointestinal (GI), respiratory, psychiatric, kidney, liver, cardiac diseases, bleeding disorder, other disease/condition or abnormal physical finding which may interfere with the study objectives, as judged by the Investigator.
    12) History of alcohol or drug abuse, or addiction within the last 2 years prior to the Screening Visit.
    13) Current or expected use of erectile dysfunction phosphodiesterase type V (PDE5) inhibitor drugs from the Screening Visit to Visit 5/Exit Visit.
    14) Current or expected use of nitrates or any nitric oxide donating drugs other than the IMP from the Screening Visit to Visit 5/Exit Visit.
    15) Current or expected use of anticoagulants from the Screening Visit to the Visit 5/Exit Visit.
    16) Any use or expected use of concurrent analgesic, anti-inflammatory therapy, from the Screening Visit to the Visit 5/Exit Visit.
    17) Oral, intramuscular and lower limb intra-articular corticosteroids within
    3 months prior to the Screening Visit. Only stable dose regimens of inhaled and topical corticosteroids are allowed during the study.
    18) Current participation or participation within 30 days prior to the Screening Visit in another investigational study.
    19) Previous enrollment in a naproxcinod (HCT 3012) clinical study or previous enrollment in the present study.
    20) Any direct involvement with the study conduct at site or any family link with study site staff.
    21) Any contra-indication to naproxen in the local country (e.g. history of stroke) or any concomitant disease that would put the patient at excessive risks (e.g. myocardial infarction), as judged by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy analysis will be based on the Intend-To-Treat (ITT) population which includes all randomized patients and will be performed on an as-randomized basis.
    Efficacy will be assessed by 3 co-primary variables:
    • Mean change from Baseline in WOMAC™ pain subscale score at Week 13,
    • Mean change from Baseline in WOMAC™ function subscale score at Week 13,
    • Mean change from Baseline in patient’s overall rating of disease status at Week 13.

    Safety evaluations
    All safety analyses will be conducted on the safety population and tabulated by treatment group. Safety variables include AEs, OBPM, heart rate, ECG, BMI, physical examinations, and laboratory tests.
    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 Yes
    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) 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 concerned23
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 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 state135
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 520
    F.4.2.2In the whole clinical trial 800
    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 Decision2007-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-01
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 19 01:59:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA