pain associated with osteoarthritis of the knee MedDRA version: 9.1 Level: LLT Classification code 10031161 Term: Osteoarthritis
Conditions
Interventions
Product Name: 2PX
Product Code: 2PX
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Strontium chloride hexahydrate
Current Sponsor code: 2PX
Concentration unit: % (W/V) percent weight/vol
Sponsors
SantoSolve A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female out-patients, 40 years or older. • Subjects who have given their written informed consent. • Subjects with documented OA of either one or both knees, as defined by the American College of Rheumatology (ACR) criteria ([Altman R, Asch E, Bloch D, et al (1986)]); i.e., o knee pain and at least 3 out of the following 6 criteria in the target joint: ? age >50 years; ? stiffness =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subjects with any moderate to severe pain of other origin (e.g., fibromyalgia) which could confound assessment or self-evaluation of pain due to OA in the target knee. • Subjects with any prosthesis fitted to the target knee. • Subjects requiring treatment with any of the following agents/therapies within the specified periods or at any time during the study are excluded from participation: • Any potent/strong opioid in the 4 weeks prior to randomisation (i.e., an opioid assumed to cause withdrawal symptoms upon abrupt discontinuation). • Any topical or subcutaneously applied analgesic agents (e.g., capsaicin, NSAIDs) applied to the target knee within 7 days prior to randomisation. • Any treatment which could alter the degree or nature of baseline OA pain planned within the study period. • Intra-articular injections of corticosteroids in the target knee within the 2 months prior to randomisation. • Intra-articular injections of hyaluronan in the target knee within 6 months prior to randomisation. • Avascular necrosis in the target knee within 6 months prior to randomisation. • Arthrosynthesis of the target knee within 12 months prior to randomisation. • Arthroscopy of the target knee within 6 months prior to randomisation. • Major trauma to the target knee within 6 months prior to randomisation. • Infection in the target knee within 6 months prior to randomisation. • Subjects who have previously been treated with 2PX. • Subjects who have received an investigational drug or used an investigational device within the 30 days prior to randomisation. • Subjects with a significant psychiatric disorder, in the opinion of the investigator, or subjects receiving strong anti-psychotic medication. • Subjects with documented or suspected alcohol or drug abuse. • Any ongoing or past history of malignant disease within the 5 years immediately prior to randomisation (with the exception of basal cell carcinoma). • Pregnancy or ongoing lactation • Female subjects of childbearing potential unwilling to use adequate contraceptive measures throughout the duration of the study. For the purpose of this study, adequate contraception is defined as: o oral, injected or implanted hormonal methods of contraception; OR o placement of an intrauterine device (IUD) or intrauterine system (IUS); OR o barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository Note: Male sterilisation or abstinence are not acceptable methods of birth control and would preclude enrolment in the study. Note: For post-menopausal women: less than 12 months since the last spontaneous menstrual bleeding will exclude the patient unless they are willing to utilise acceptable methods of contraception for the duration of the study. • Male subjects able to conceive, who are unwilling to use barrier methods of contraception thoughout the duration of the study • Subjects unable to comply with the study assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of topically administered 2PX versus placebo (vehicle) control in terms of reduction in pain intensity and physical function. ;Secondary Objective: To prospectively measure other efficacy variables of topically administered 2PX in pain associated with osteoarthritis of the knee. To evaluate the safety and tolerability of topically administered 2PX. ;Primary end point(s): The primary efficacy endpoints are the difference between the active and placebo group in the change from Baseline to the assessment after 26 weeks of treatment in the actual WOMAC Osteoarthritis Index LK 3.1 subscale score for pain and physical function. | — |
Countries
Finland, United Kingdom
Outcome results
None listed