A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-336 as an Adjunct to Diet and Exercise in Obese Individuals with Osteoarthritis of the Knee

Conditions

Knee osteoarthritis, Obesity

Brief summary

The proportional change from baseline in body weight at Day 183, OR The change from baseline in the WOMAC pain scale at Day 183

Detailed description

Change from baseline in WOMAC stiffness and WOMAC function scales during the trial and at Day 183, Proportion of subjects reaching ≥5, ≥10 or ≥15% weight loss from baseline at Day 183, Proportion of subjects reaching ≥30 and ≥50% reduction in WOMAC pain scale from baseline at Day 183, Change from baseline in AQol 8D at Day 183, Change from baseline in AQol 8D subscore Independent living at Day 183, Change from baseline in the weekly average of daily pain during the trial, and at Day 183, Area under the curve from baseline in the weekly average of daily pain to Day 183, Change from baseline to Day 183 in waist-to-hip ratio, Change from baseline in whole body composition by DXA at Day 183, Change from baseline in bone mineral density of the lumber spine, femoral head, and total hip by DXA at Day 183, Change from baseline in PGA at Day 183, OMERACT-OARSI responder rates at Day 183, Average weekly days using rescue medication

Related papers

No related papers found yet.

Interventions

DRUGPanodil

DRUGfilmovertrukne tabletter 500 mg (Ny formulering)

DRUGMatching Placebo

DRUGKBP-336

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The proportional change from baseline in body weight at Day 183, OR The change from baseline in the WOMAC pain scale at Day 183	—

Secondary

Measure	Time frame
Change from baseline in WOMAC stiffness and WOMAC function scales during the trial and at Day 183, Proportion of subjects reaching ≥5, ≥10 or ≥15% weight loss from baseline at Day 183, Proportion of subjects reaching ≥30 and ≥50% reduction in WOMAC pain scale from baseline at Day 183, Change from baseline in AQol 8D at Day 183, Change from baseline in AQol 8D subscore Independent living at Day 183, Change from baseline in the weekly average of daily pain during the trial, and at Day 183, Area under the curve from baseline in the weekly average of daily pain to Day 183, Change from baseline to Day 183 in waist-to-hip ratio, Change from baseline in whole body composition by DXA at Day 183, Change from baseline in bone mineral density of the lumber spine, femoral head, and total hip by DXA at Day 183, Change from baseline in PGA at Day 183, OMERACT-OARSI responder rates at Day 183, Average weekly days using rescue medication	—

Measure

Time frame

Change from baseline in WOMAC stiffness and WOMAC function scales during the trial and at Day 183, Proportion of subjects reaching ≥5, ≥10 or ≥15% weight loss from baseline at Day 183, Proportion of subjects reaching ≥30 and ≥50% reduction in WOMAC pain scale from baseline at Day 183, Change from baseline in AQol 8D at Day 183, Change from baseline in AQol 8D subscore Independent living at Day 183, Change from baseline in the weekly average of daily pain during the trial, and at Day 183, Area under the curve from baseline in the weekly average of daily pain to Day 183, Change from baseline to Day 183 in waist-to-hip ratio, Change from baseline in whole body composition by DXA at Day 183, Change from baseline in bone mineral density of the lumber spine, femoral head, and total hip by DXA at Day 183, Change from baseline in PGA at Day 183, OMERACT-OARSI responder rates at Day 183, Average weekly days using rescue medication

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Countries

Czechia, Denmark, Poland, Romania

Outcome results

None listed