Prospective Multicenter Non-interventional Study in Patients With Knee or Hip Osteoarthritis Having a Theraflex Treatment

Bayer

Status

Completed

Conditions

Osteoarthritis

Treatments

Drug: Theraflex, BAY 874017

Study type

Observational

Funder types

Industry

Identifiers

NCT03330288

19649

Details and patient eligibility

About

The main purpose of this study is to evaluate how a long-term treatment with Theraflex during 64 weeks affects pain intensity in the affected knee or hip joint, the activity in daily living, the quality of life and patient satisfaction with treatment.

Full description

Other information that is planned for evaluation in this study includes consumption of Theraflex, intake of analgesics for joint pain relief and description of basic patient characteristics such as age, weight and body mass index and others.

Enrollment

1,102 patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients 45 to 75 years with Hip or Knee OA stage I to III
Patient started current treatment with Theraflex not more than 2 weeks prior to inclusion into the study
Personally signed and dated informed consent

Exclusion criteria

Patients participating in an investigational program with interventions outside of routine clinical practice
Patients with Hip or Knee OA stage 0 or stage IV
Patients who have both Hip and Knee OA and OA of any other location
Contraindications for use of Theraflex in accordance with approved label(known hypersensitivity, severe chronic renal failure)
Females who are pregnant or breastfeeding
Patients who completed a treatment with Theraflex or another combination of Gl+ Ch less than 5 months before start of the current treatment
Patients who completed intra-articular corticosteroids treatment in the last 3 months to exclusion criteria
Patients who completed hyaluronic injections of the lower limbs in the last 6 months