Table 1.

Designs of pivotal Supartz clinical trials for Japan and United States regulatory approval.

Study/country	N	Inclusion criteria	Treatment/study duration	Co-interventions permitted	Outcomes
Oshima et al31/Japan	206	Symptomatic and radiographic evidence of knee OA; age ⩾18 years	4-8 wk/4-8 wk	Prior anti-inflammatory or analgesic medication or physical therapy	Pain while at rest, walking, going up/down stairs pain, during flexion/extension; oppressive pain (tenderness); swelling; patellar ballottement; synovial effusion; ROM; impairment in ADLs; patient- and clinician-rated global improvement
Shichikawa et al32/Japan	107	Radiographic knee OA with pain on movement; age ⩾18 years	5 wk/5 wk	Prior physical therapy	Pain while at rest, walking, going up/down stairs pain, during flexion/extension; oppressive pain (tenderness); swelling; patellar ballottement; synovial effusion; ROM; impairment in ADLs; patient- and clinician-rated global improvement
Shichikawa et al33/Japan	228	Radiographic knee OA with pain on exercise; age ⩾18 years	5 wk/5 wk	Prior anti-inflammatory medication or physical therapy	Pain while at rest, walking, going up/down stairs pain, duringflexion/extension; oppressive pain (tenderness); swelling; patellar ballottement; synovial effusion; ROM; impairment in ADLs; patient- and clinician-rated global improvement
Puhl et al34/Germany	209	Radiographic knee OA; age 40-75 years	5 wk/14 wk	Paracetamol rescue	Primary: Lequesne, paracetamol use Secondary: VAS, investigator/patient global assessment
Lohmander et al35/Sweden	240	Radiographic OA; VAS ⩾10 mm; age 40-75 years; Lequesne score ⩾4 at baseline	5 wk/20 wk	Paracetamol rescue	Primary: Lequesne, VAS ratings for knee function, pain, ROM, and activity level Secondary: paracetamol use, investigator/patient global assessment
Day et al36/Australia	203	Mild/moderate early OA; pain on walking; age 40-75 years	5 wk/18 wk	Paracetamol rescue	Primary: WOMAC pain, stiffness, and disability Secondary: Lequesne, paracetamol use, investigator and patient global assessment
United Kingdom (unpublished)37	231	Radiographic OA; moderate pain >3 months	5 wk/25 wk	Co-proxomol as rescue	Primary: VAS pain Secondary: Lequesne, paracetamol use, investigator/patient global assessment
France (unpublished)37	254	Radiographic OA; VAS global pain ⩾35 mm	5 wk/13 wk 3 wk/13 wk	Paracetamol as rescue	Primary: Lequesne Secondary: VAS pain, paracetamol use, investigator global assessment

Abbreviations: ADL, activities of daily living; OA, osteoarthritis; ROM, range of motion; VAS, visual analog scale; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.