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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many locations Many locations, Russia | Status Recruiting | Contact Us: E-mail: [email protected] Phone: +1-888-8422937 |
Locations Sci-Res Institute of Rheumatology n.a. V.A. Nasonova of RAMS Moscow, Russia, 115522 | Status Completed | Contact Us: E-mail: [email protected] Phone: +1-888-8422937 |
Trial Design
Prospective multicenter non-interventional study in patients with knee or hip osteoarthritis having a Theraflex® treatment to evaluate changes in pain, functions in daily living, and quality of life for an observation period up to 64 weeks
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Changes in quality of life assessed by Knee injury and Osteoarthritis Outcome Score (KOOS) in patients with knee OAChanges in pain, other symptoms, functions and knee related quality of life assessment will all be collected by KOOS questionnaireTimeframe: Up to 64 weeks
- Changes in quality of life assessed by Hip injury and Osteoarthritis Outcome Score (HOOS) in patients with hip OAChanges in pain, others symptoms, functions and hip related quality of life assessment will all be collected by HOOS questionnaireTimeframe: Up to 64 weeks
Secondary Outcome
- Drug utilization of Theraflex therapyas reported by the patient to their physicianTimeframe: Up to 64 weeks
- Patient satisfaction measured with a Likert response scalemeasured with a Likert response scale (from 1-very dissatisfied to 5 – very satisfied)Timeframe: Up to 64 weeks
- Painkiller usage - typeTimeframe: Up to 64 weeks
- Painkiller usage - lengthTimeframe: Up to 64 weeks
- Painkiller usage - frequencyTimeframe: Up to 64 weeks
- Other medical/physical therapy usage-typeTimeframe: Up to 64 weeks
- Other medical/physical therapy usage-frequencyTimeframe: Up to 64 weeks
- Other medical/physical therapy usage-lengthTimeframe: Up to 64 weeks
Additional Information
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