?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 in Patients with Osteoarthritis of the Hip? - HCT 3012-X-303
- Conditions
- Osteoarthritis of the Hip (OA)MedDRA version: 9.1Level: LLTClassification code 10024776Term: Localised osteoarthritis
- Registration Number
- EUCTR2007-000078-21-IT
- Lead Sponsor
- ICOX S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
To be eligible for the study, patients must fulfill the following 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: Western Ontario and MacMaster Universities Osteoarthritis Index (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) no
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 mol/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, within the last 6 months prior to the Screening Visit. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: The secondary objectives of this study are: 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. To evaluate the general safety and tolerability of naproxcinod 750 mg bid vs. placebo bid and naproxen 500 mg bid.;Primary end point(s): Three co-primary efficacy variables have been identified as follows: WOMAC? pain subscale score at Week 13. WOMAC? function subscale score at Week 13. Patient?s overall rating of disease status at Week13.
- Secondary Outcome Measures
Name Time Method