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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 1

Conditions

Osteoarthritis

Treatments

Drug: Ibuprofen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00372801
COX103843

Details and patient eligibility

About

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.

Sex

All

Ages

Under 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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