A Study of the Efficacy and Safety of 2PX in Patients With Pain Due to Osteoarthritis of the Knee
NCT ID: NCT00954629
Last Updated: 2010-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
2009-06-30
2010-05-31
Brief Summary
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Detailed Description
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Secondary objectives: 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2PX
Pain medication
strontium chloride hexahydrate
Topical solution to be applied twice daily for 26 weeks. Dosage of up till 4 ml per application.
Placebo
Placebo
Topical solution to be applied twice daily for 26 weeks. Dosage up till 4ml per application.
Interventions
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strontium chloride hexahydrate
Topical solution to be applied twice daily for 26 weeks. Dosage of up till 4 ml per application.
Placebo
Topical solution to be applied twice daily for 26 weeks. Dosage up till 4ml per application.
Eligibility Criteria
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Inclusion Criteria
* 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.knee pain and at least 3 out of the following 6 criteria in the target joint:
* age \>50 years
* stiffness \< 30 minutes
* crepitus
* bony tenderness
* bony enlargement
* no palpable warmth
* Radiological evidence of joint space narrowing in the target joint within 8 weeks prior to randomisation.
* Subjects with chronic, moderate to severe OA pain of the target knee:
* present for more than 3 months, and for ≥ 20 days per month.
* not controlled by, or intolerant of, oral NSAIDs, paracetamol, COX-2 inhibitors or weak opioids.
* intensity at least moderate (i.e., actual WOMAC (pain questions 1-5) ≥ 10) on WOMAC OA index LK 3.1 at Visit 1, in the target knee, as recalled over the last 24 hours.
Exclusion Criteria
* 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:
* oral, injected or implanted hormonal methods of contraception; OR
* placement of an intrauterine device (IUD) or intrauterine system (IUS); OR
* 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 throughout the duration of the study
* Subjects unable to comply with the study assessments.
40 Years
ALL
No
Sponsors
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SantoSolve AS
INDUSTRY
Smerud Medical Research International AS
OTHER
Responsible Party
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SantoSolve AS
Principal Investigators
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Stuart Ratcliffe, MD
Role: PRINCIPAL_INVESTIGATOR
MAC Neuroscience centre in Blackpool, United Kingdom
Locations
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Site in Helsinki
Helsinki, , Finland
Site at Kuopio
Kuopio, , Finland
Site in Turku
Turku, , Finland
Site in Bialystok
Bialystok, , Poland
Site in Kraków
Krakow, , Poland
Site in Warszawa
Warsaw, , Poland
Site in St-Petersburg
Saint Petersburg, , Russia
Site in St-Petersburg
Saint Petersburg, , Russia
Site in Blackpool
Blackpool, , United Kingdom
Site in Bolton
Bolton, , United Kingdom
Site in Bradford
Bradford, , United Kingdom
Site in Manchester
Manchester, , United Kingdom
Site at Cheadle Hulme
Stockport, , United Kingdom
Site at Heald Green
Stockport, , United Kingdom
Site at Heaton Moor
Stockport, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2PX-OA-03
Identifier Type: -
Identifier Source: org_study_id
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