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

NCT03330288 | Completed Results

• 1 other identifier: 19649
• Study Type: observational
• Target: 1,102
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Changes in the Pain Intensity Subscale

  KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Pain intensity is one subscale of KOOS and HOOS questionnaire, each pain intensity question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS pain intensity subscale were calculated as \[100 - (mean value of all subscale questions \* 100) / 4\]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS pain intensity subscale results calculation used a similar method.

  From enrollment up to 64 weeks

• Changes in Other Symptoms Subscale

  KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Other symptoms is one subscale of KOOS and HOOS questionnaire, each other symptoms question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS other symptoms subscale were calculated as \[100 - (mean value of all subscale questions \* 100) / 4\]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS other symptoms subscale results calculation used a similar method.

  From enrollment up to 64 weeks

• Change in Functional Activity of the Joint Subscale

  KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Functional activity is one subscale of KOOS and HOOS questionnaire, each functional activity question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS functional activity subscale were calculated by converting value of all subscale questions to KOOS-Physical Short form score. Results score is from 0 to 100, 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS functional activity subscale results used a similar method with HOOS-Physical Short form.

  From enrollment up to 64 weeks

• Change in Life Quality Subscale

  KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Life quality is one subscale of KOOS and HOOS questionnaire, each life quality question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS life quality subscale were calculated as \[100 - (mean value of all subscale questions \* 100) / 4\]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS life quality subscale results calculation used a similar method.

  From enrollment up to 64 weeks

Secondary Outcomes (4)

• Number of Participant Compliance With Drug Utilization of Theraflex

  From enrollment up to 64 weeks

• Change in Patient Satisfaction Assessment

  From enrollment up to 64 weeks

• Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA)

  From enrollment up to 64 weeks

• Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) Used After the Completion of Treatment With Theraflex

  From enrollment up to 64 weeks

Study Arms (2)

Participants with Stage I-III Knee osteoarthritis (KOA)

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

Drug: Theraflex, BAY 874017

Participants with Stage I-III Hip osteoarthritis (HOA)

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

Drug: Theraflex, BAY 874017

Interventions

Theraflex, BAY 874017 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 with Stage I-III Knee osteoarthritis (KOA)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients 45 to 75 years with Hip or Knee OA stage I to III
• Personally signed and dated informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

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

Moscow, 115522, Russia

Location

Many locations

Multiple Locations, Russia

Location

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: November 6, 2017
• Study Start: November 20, 2017
• Primary Completion: March 18, 2020
• Study Completion: July 13, 2020
• Last Updated: October 14, 2021
• Results First Posted: October 14, 2021

Record last verified: 2021-09

Locations

RU (2)