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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
  Purpose

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 Intervention Phase
Osteoarthritis
 Drug: Ibuprofen
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by BioChemics, Inc.:

Primary Outcome Measures:
  • Visual Analogue Scale (VAS) Pain scale [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: February 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496326

Locations
Switzerland
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.
Investigators
Study Director: Stephen Carter, Ph.D. BioChemics, Inc.
  More Information

No publications provided

Responsible Party: BioChemics, Inc.
ClinicalTrials.gov Identifier: NCT01496326     History of Changes
Other Study ID Numbers: BC-IBU-CH-001
Study First Received: December 15, 2011
Last Updated: December 19, 2011
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by BioChemics, Inc.:
Osteoarthritis
knee pain

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013