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

NCT ID: NCT03330288

Last Updated: 2021-10-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-20

Study Completion Date

2020-07-13

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Stage I-III Knee osteoarthritis (KOA)

Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment

Theraflex, BAY 874017

Intervention Type DRUG

The first three weeks which do have a different posology (3 capsules a day) according to the label should be entered as a distinct period to the treatment period with a recommended posology of 2 capsules a day

Participants with Stage I-III Hip osteoarthritis (HOA)

Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment

Theraflex, BAY 874017

Intervention Type DRUG

The first three weeks which do have a different posology (3 capsules a day) according to the label should be entered as a distinct period to the treatment period with a recommended posology of 2 capsules a day

Interventions

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Theraflex, BAY 874017

The first three weeks which do have a different posology (3 capsules a day) according to the label should be entered as a distinct period to the treatment period with a recommended posology of 2 capsules a day

Intervention Type DRUG

Eligibility Criteria

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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 hyaluronic injections of the lower limbs in the last 6 months
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Moscow, , Russia

Site Status

Many locations

Multiple Locations, , Russia

Site Status

Countries

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Russia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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19649

Identifier Type: -

Identifier Source: org_study_id