Clinical trial NCT03330288: Prospective Multicenter Non-interventional Study in Patients With Knee or Hip Osteoarthritis Having a Theraflex Treatment
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 1102
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who will be made aware about the study either by the treating physician OR by a pharmacist where a patient is purchasing Theraflex

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 quality of life and patient satisfaction with treatment.

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 age, weight and body mass index and others.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the Pain Intensity Subscale
timeFrame: From enrollment up to 64 weeks
measure: Changes in Other Symptoms Subscale
timeFrame: From enrollment up to 64 weeks
measure: Change in Functional Activity of the Joint Subscale
timeFrame: From enrollment up to 64 weeks
measure: Change in Life Quality Subscale
timeFrame: From enrollment up to 64 weeks
Secondary outcomes:
measure: Number of Participant Compliance With Drug Utilization of Theraflex
timeFrame: From enrollment up to 64 weeks
measure: Change in Patient Satisfaction Assessment
timeFrame: From enrollment up to 64 weeks
measure: Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA)
timeFrame: From enrollment up to 64 weeks
measure: Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) Used After the Completion of Treatment With Theraflex
timeFrame: From enrollment up to 64 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sci-Res Institute of Rheumatology n.a. V.A. Nasonova of RAMS
city: Multiple Locations
country: Russian Federation
facility: Many locations
Study officials:
References: