Trial | NCT01496326  Report issue

Title

Osteoarthritis Topical Treatment
A Pilot Study to Compare the Efficacy and Safety of a Novel 10% Ibuprofen Formulation Versus Placebo Alone Applied to the Knee in Patients With Painful Osteoarthritis of the Knee

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ibuprofen ...

  • Study Participants

    75
This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment of ibuprofen compared to the use of a placebo topical treatment.

A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days Dosing twice daily (b.i.d.)
Study Started
Feb 28
2011
Primary Completion
Aug 31
2011
Study Completion
Aug 31
2011
Last Update
Dec 21
2011
Estimate

Drug Ibuprofen

10% ibuprofen cream formulation at a dose of 200mg

Drug placebo

2 grams of placebo cream for 14 days

Ibuprofen Experimental

Placebo Placebo Comparator

Criteria 

Main Inclusion Criteria:

Male or female patients aged at least 40 years.
Primary osteoarthritis in a single knee joint, grade II/III based on the Kellgren and Lawrence classification system.
Radiographic evidence consistent with osteoarthritis carried out within 6 months before screening.
pain is currently not adequately controlled with a simple analgesic or an NSAID OR would necessitate treatment, but is not yet treated.

Main Exclusion Criteria:

Concomitant presence of another type of continuous pain that is more severe in intensity in comparison with the osteoarthritis target joint pain
Osteoarthritis causing significant pain in any joint other than the identified knee, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at visit 1 for any other painful joint concerned.
Female patients who are pregnant or breast-feeding.
No Results Posted