E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoarthritis of the Hip (OA) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024776 |
E.1.2 | Term | Localised osteoarthritis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
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 |
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E.4 | Principal 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 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. |
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E.5 End points |
E.5.1 | 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. Patients overall rating of disease status at Week13. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | 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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |