Tracking Information
Start Date ICMJE | June 2009 |
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Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: August 6, 2009) | 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. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00954629 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: August 6, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Study of the Efficacy and Safety of 2PX in Patients With Pain Due to Osteoarthritis of the Knee |
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Official Title ICMJE | A 26 Week Placebo-controlled, Randomised, Double-blind, Parallel Group Study of the Efficacy and Safety of 2PX (Topical Strontium Chloride Hexahydrate) in Patients With Pain Due to Osteoarthritis of the Knee |
Brief Summary | The purpose of the study is to demonstrate the superiority of topically administered 2PX versus placebo (vehicle) control in terms of reduction in pain intensity and physical function. |
Detailed Description | Primary objective: To demonstrate the superiority of topically administered 2PX versus placebo (vehicle) control in terms of reduction in pain intensity and physical function. 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. |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 300 | ||||
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Estimated Completion Date | May 2010 | ||||
Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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.
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Gender | Both | ||||
Ages | 40 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Finland, Poland, Russian Federation, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00954629 | ||||
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Responsible Party | Thorfinn Ege, SantoSolve AS | ||||
Study ID Numbers ICMJE | 2PX-OA-03 | ||||
Study Sponsor ICMJE | Smerud Medical Research International AS | ||||
Collaborators ICMJE | SantoSolve AS | ||||
Investigators ICMJE |
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Information Provided By | Smerud Medical Research International AS |