Osteoarthritis of the Hip MedDRA version: 9.1 Level: LLT Classification code 10020108 Term: Hips osteoarthritis
Conditions
Interventions
Product Name: Naproxcinod capsules
Product Code: HCT 3012
Pharmaceutical Form: Capsule*
INN or Proposed INN: Naproxcinod
CAS Number: 163133-43-5
Current Sponsor code: HCT 3012
Concentration unit: mg m
Sponsors
NicOx S.A
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria
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, 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 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. ;Primary 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. | — |
Countries
Belgium, Bulgaria, Germany, Italy, Spain, United Kingdom
Outcome results
None listed