Trial Condition(s):

Osteoarthritis

Prospective multicenter non-interventional study in patients with knee or hip osteoarthritis having a Theraflex treatment

Bayer Identifier:

19649

ClinicalTrials.gov Identifier:

NCT03330288

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
1110
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Theraflex® (Glucosamine hydrochloride/Chondroitin sodium sulfate, BAY874017)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, Russia

Status
Recruiting
 
Locations

Sci-Res Institute of Rheumatology n.a. V.A. Nasonova of RAMS

Moscow, Russia, 115522

Status
Completed
 

Trial Design