Osteoarthritis Topical Treatment

Osteoarthritis Clinical Trial

— ANTIPAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496326
• Other study ID #: BC-IBU-CH-001
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2011
• Last updated: December 19, 2011
• Start date: February 2011
• Est. completion date: August 2011

Study information

• Verified date: December 2011
• Source: BioChemics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Ibuprofen
10% ibuprofen cream formulation at a dose of 200mg
• placebo
2 grams of placebo cream for 14 days

Locations

Country	Name	City	State
Switzerland	Rheumaklinik und Institut für Physikalische Medizin Universitätsspital	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
BioChemics, Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS) Pain scale		14 days	No