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OpenTrials
Completed

NCT Number: NCT00372801

Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee

To demonstrate that new drugs work, many complex multidose studies are often required. The intent of this study is to use Ibuprofen as an example of a marketed pain relief drug to validate a simpler single dose model for future assessment of new pain drugs.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Randwick, Sydney, New South Wales, 2031, Australia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects diagnosed with primary Osteoarthritis of the knee.
  • Have at least 3 months in symptom duration prior to screening visit.
  • Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective cyclo-oxygenase II (COX2) inhibitor for management of knee pain.
  • Pain walking on flat surface within specific interval prior to study start.

Exclusion criteria

  • History of hypersensitivity to NSAIDS.
  • Allergy to Ibuprofen.
  • Use of assistive devices other than a cane or knee brace.
  • History of specified diseases/illnesses.
  • Abnormal blood tests pre-study.

Treatment and study plan

Ibuprofen

Drug

Primary outcomes

  1. Pain intensity recorded over 0-8 hours using question 1 of the WOMAC (Western Ontario and McMaster University Osteoarthritis Index)pain subscale (visual analog scale).

Secondary outcomes

  1. Responder rate Patient impression of change - 8 & 24 hrs post dose Time to use of rescue medication (paracetamol)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Pilot Study to Investigate the Efficacy of Ibuprofen in Patients With Osteoarthritis of the Knee Following Administration of a Single Dose

Important dates

Study start
2005
First posted
Sep 7, 2006
Registry last updated
Oct 16, 2008

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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