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
- Conditions
- Osteoarthritis of the HipMedDRA version: 9.1Level: LLTClassification code 10020108Term: Hips osteoarthritis
- Registration Number
- EUCTR2007-000078-21-DE
- Lead Sponsor
- icOx S.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method