Status:
COMPLETED
Prospective Multicenter Non-interventional Study in Patients With Knee or Hip Osteoarthritis Having a Theraflex Treatment
Lead Sponsor:
Bayer
Conditions:
Osteoarthritis
Eligibility:
All Genders
45-75 years
Brief Summary
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 quali...
Detailed 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 ag...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 13 2020
Estimated Enrollment :
1102 Patients enrolled
Trial Details
Trial ID
NCT03330288
Start Date
November 20 2017
End Date
July 13 2020
Last Update
October 14 2021
Active Locations (2)
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1
Sci-Res Institute of Rheumatology n.a. V.A. Nasonova of RAMS
Moscow, Russia, 115522
2
Many locations
Multiple Locations, Russia