Patients with osteoarthritis of the knee
Conditions
Interventions
Product Name: 2PX
Product Code: 2PX
Pharmaceutical Form: Cutaneous solution
Pharmaceutical form of the placebo: Cutaneous solution
Route
Sponsors
Santosolve A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At Visit 1: 1. Males and female out-patients, 18 years or older. 2. Subjects who have given their written informed consent. 3. Subjects with documented OA of the knee [as defined by the American College of Rheumatology] 4. Subjects with chronic pain, from which they have been suffering for more than three months for at least 20 days per month. 5. Subjects with moderate to severe OA pain of the target joint, whose pain is not adequately controlled by paracetamol or NSAIDs. 6. Pain intensity score of ?4 (on an 11-point NRS) at Visit 1 (average daily score as recalled over each of the last seven days) in the target knee. 7. Female subjects of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative urine pregnancy test. At Visit 2: 1. Prior to randomisation, subjects must report an improvement in their average daily (diary) pain intensity by at least two points on the 11-point NRS compared to Visit 1, based upon at least four out of seven days during Week 2. 2. To be eligible for randomisation, subjects must report an improvement in their recalled clinic pain intensity by at least two points on the 11-point NRS compared to Visit 1. 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. Subjects who have received treatment with a potent opioid in the four weeks preceding study entry. 2. Subjects to whom any of the following applies: a. Major trauma to the target joint in the preceding six months; b. Infection in the target joint in the preceding six months; c. Avascular necrosis in the target joint in the preceding six months; d. Intra-articular injections of corticosteroids in the target joint in the preceding two months, or hyaluronan injections in the target joint in the preceding six months; e. Arthrosynthesis in the preceding year or arthroscopy in the preceding six months. 3. Subjects who have started any form of physiotherapy or massage affecting the target joint in the three weeks preceding the study. 4. Subjects for whom a treatment that could alter the degree or nature of pain is planned within the study period. 5. Subjects with any moderate to severe pain, e.g. fibromyalgia, which could confound assessment or self-evaluation of pain due to OA. 6. Subjects using topically applied analgesic compounds on the area affected by OA, e.g. capsaicin, topical NSAIDs (stable doses of oral NSAIDs/COX-2 inhibitors are allowed, provided that these have been stable for one month prior to Visit 1. Opioids and tramadol are not allowed). 7. Subjects with documented or suspected alcohol or drug abuse. 8. Subjects known to have a condition that, in the investigator’s judgement, precludes participation in the study. 9. Subjects with a significant psychiatric disorder, in the opinion of the investigator, or subjects receiving strong anti-psychotic medication. 10. Female subjects who are pregnant or breast feeding. 11. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry. 12. Subjects unable to comply with the study assessments or to complete the questionnaires. 13. Subjects who have previously been admitted to this study. 14. Subjects who are shown to have abnormal haematology and biochemistry results at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of 2PX versus placebo in patients with pain due to osteoarthritis of the knee.;Secondary Objective: The secondary objective is to evaluate the tolerability, and local and systemic effects of 2PX.;Primary end point(s): The primary efficacy variable is the “time to exit” during the double-blind phase. Subjects will exit the double-blind phase if their daily diary pain intensity score deteriorates by two or more points on the 11-point NRS on two consecutive days in comparison to the pain intensity at Visit 2. | — |
Countries
United Kingdom
Outcome results
None listed