A placebo-controlled, double-blinded, randomized, dose-finding trial using a combination of apocynin and paeonol (APPA) for the treatment of knee osteoarthritis

Conditions

Knee osteoarthritis

Brief summary

The primary endpoint of this trial is the change from baseline in WOMAC pain sub-score (sum of questions 1 to 5) of the target knee as evaluated at week 12.

Detailed description

Changes from baseline in WOMAC total score and the WOMAC function and stiffness scores at week 12, Changes from baseline in constant, intermittent and total OA pain assessed by ICOAP scores at week 12, Changes from baseline in WOMAC pain weight-bearing score (questions 1, 2, and 5) and non-weight bearing score (questions 3 and 4) at week 12, Change from baseline in the weekly mean of the average daily NRS pain intensity at Week 12, Area-under-effect curves of the weekly mean of the average daily NRS pain intensity at Week 12, OMERACT-OARSI responder rate at week 12, Total number of days where rescue medication was reported used for treatment of target knee pain, Total dose of rescue medication calculated as the sum of tablets used, based on pill counts, Changes from baseline in the Patient Global Assessment (PGA) score at week 12, Changes from baseline in quality of life assessed by the EQ5D at week 12, Nature, incidence and severity of AEs, Changes in laboratory safety parameters, vital signs, ECG parameters, and weight

Related papers

No related papers found yet.

Interventions

DRUGMatching placebo

DRUGAPPA

DRUGPanodil

DRUGfilmovertrukne tabletter 500 mg (Ny formulering)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this trial is the change from baseline in WOMAC pain sub-score (sum of questions 1 to 5) of the target knee as evaluated at week 12.	—

Secondary

Measure	Time frame
Changes from baseline in WOMAC total score and the WOMAC function and stiffness scores at week 12, Changes from baseline in constant, intermittent and total OA pain assessed by ICOAP scores at week 12, Changes from baseline in WOMAC pain weight-bearing score (questions 1, 2, and 5) and non-weight bearing score (questions 3 and 4) at week 12, Change from baseline in the weekly mean of the average daily NRS pain intensity at Week 12, Area-under-effect curves of the weekly mean of the average daily NRS pain intensity at Week 12, OMERACT-OARSI responder rate at week 12, Total number of days where rescue medication was reported used for treatment of target knee pain, Total dose of rescue medication calculated as the sum of tablets used, based on pill counts, Changes from baseline in the Patient Global Assessment (PGA) score at week 12, Changes from baseline in quality of life assessed by the EQ5D at week 12, Nature, incidence and severity of AEs, Changes in laboratory safety parameters, vit	—

Measure

Time frame

Changes from baseline in WOMAC total score and the WOMAC function and stiffness scores at week 12, Changes from baseline in constant, intermittent and total OA pain assessed by ICOAP scores at week 12, Changes from baseline in WOMAC pain weight-bearing score (questions 1, 2, and 5) and non-weight bearing score (questions 3 and 4) at week 12, Change from baseline in the weekly mean of the average daily NRS pain intensity at Week 12, Area-under-effect curves of the weekly mean of the average daily NRS pain intensity at Week 12, OMERACT-OARSI responder rate at week 12, Total number of days where rescue medication was reported used for treatment of target knee pain, Total dose of rescue medication calculated as the sum of tablets used, based on pill counts, Changes from baseline in the Patient Global Assessment (PGA) score at week 12, Changes from baseline in quality of life assessed by the EQ5D at week 12, Nature, incidence and severity of AEs, Changes in laboratory safety parameters, vit

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Countries

Denmark

Outcome results

None listed