NCT00954629

A Study of the Efficacy and Safety of 2PX in Patients With Pain Due to Osteoarthritis of the Knee

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Smerud Medical Research International AS · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Osteoarthritis

Interventions

Type	Name	Description
DRUG	strontium chloride hexahydrate	Topical solution to be applied twice daily for 26 weeks. Dosage of up till 4 ml per application.
DRUG	Placebo	Topical solution to be applied twice daily for 26 weeks. Dosage up till 4ml per application.

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-08-07
• Last updated: 2010-03-24

Locations

15 sites across 4 countries: Finland, Poland, Russia, United Kingdom