Dexibuprofen 400 mg Sachet Versus Ibuprofen 400 mg Sachet in Patients With Osteoarthritis of the Hip or Knee

Gebro Pharma

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis of the Hip or Knee

Treatments

Drug: Dexibuprofen

Drug: Ibuprofen

Study type

Interventional

Funder types

Industry

Identifiers

NCT01066676

IV/48.4

Details and patient eligibility

About

Medical condition under investigation: Osteoarthritis of the hip or knee

Number of patients planned: 480 adult patients

Main objective: To evaluate and compare the tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee

Secondary objectives: To compare the overall efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee

Enrollment

482 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

male or female patients aged between 18 and 75 years
everyday joint pain for the past three months
global pain intensity in the involved joint (hip or knee) of "moderate" to "severe" within the last 48 h

Exclusion criteria

acute inflammation or ischaemic necrosis
paget's disease, chondrocalcinosis, ochronosis of the hip/knee joint
slowly progressing hip/knee arthropathy in particular of tuberculosis aetiology
hip/knee arthropathy due to diabetes mellitus
Charcot's joint
villous synovitis
chondromatosis of the synovium
patients with existing gastritis or existing ulcers or bleedings in the gastrointestinal tract or patients with history of gastrointestinal ulcers or gastrointestinal haemorrhage in the past 6 months