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OpenTrials
Completed

NCT Number: NCT01496326

Osteoarthritis Topical Treatment

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.)

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sankt Gallen, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ibuprofen

Drug

10% ibuprofen cream formulation at a dose of 200mg

Placebo

Drug

2 grams of placebo cream for 14 days

Primary outcomes

  1. Visual Analogue Scale (VAS) Pain scale

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

BioChemics, Inc.

Industry

Registry information

Official study 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

Acronym: ANTIPAIN

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 21, 2011
Registry last updated
Dec 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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