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Osteoarthritis Topical Treatment (ANTIPAIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioChemics, Inc.
ClinicalTrials.gov Identifier:
NCT01496326
First received: December 15, 2011
Last updated: December 19, 2011
Last verified: December 2011
History of Changes

December 15, 2011
December 19, 2011
February 2011
August 2011   (final data collection date for primary outcome measure)
Visual Analogue Scale (VAS) Pain scale [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01496326 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.)
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
  • Drug: Ibuprofen
    10% ibuprofen cream formulation at a dose of 200mg
  • Drug: placebo
    2 grams of placebo cream for 14 days
  • Experimental: Ibuprofen
    Intervention: Drug: Ibuprofen
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01496326
BC-IBU-CH-001
Yes
BioChemics, Inc.
BioChemics, Inc.
Not Provided
Study Director: Stephen Carter, Ph.D. BioChemics, Inc.
BioChemics, Inc.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP