Osteoarthritis Topical Treatment (ANTIPAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01496326
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : December 21, 2011
Information provided by (Responsible Party):
BioChemics, Inc.

Brief 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.)

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Ibuprofen Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Ibuprofen Drug: Ibuprofen
10% ibuprofen cream formulation at a dose of 200mg

Placebo Comparator: Placebo Drug: placebo
2 grams of placebo cream for 14 days

Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) Pain scale [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01496326

Schaffhausen, Switzerland, 8200
St. Gallen, Switzerland, 9000
Zürich, Switzerland, 8001
Zürich, Switzerland, 8050
Rheumaklinik und Institut für Physikalische Medizin Universitätsspital
Zürich, Switzerland, 8091
Sponsors and Collaborators
BioChemics, Inc.
Study Director: Stephen Carter, Ph.D. BioChemics, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: BioChemics, Inc. Identifier: NCT01496326     History of Changes
Other Study ID Numbers: BC-IBU-CH-001
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: December 21, 2011
Last Verified: December 2011

Keywords provided by BioChemics, Inc.:
knee pain

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action