Knee osteoarthritis
Conditions
Brief summary
A clodronate dose will be considered as effective when a ≥ 8.5 mm reduction in the VAS of knee pain will be observed at Week 7 vs. Placebo.
Detailed description
Mean changes in the VAS of knee pain observed at each other visit than Week 7 vs. Placebo and vs Baseline., Mean changes in the VAS of knee pain observed 120 minutes after IA injection at Baseline, Weeks 1, 2 and 3 vs predose assessment., Mean changes in the Lequesne Algo-functional Index at each visit vs Placebo and vs Baseline., Mean changes in the WOMAC Index at each visit vs Placebo and vs Baseline., Mean changes in the Range of Motion at each visit vs Placebo and vs Baseline., Use of rescue drug consumption (paracetamol) across the patients visits.
Interventions
DRUGdisodium clodronate
DRUGThe Placebo composition is identical to the IMP
Sponsors
Spa Societa Prodotti Antibiotici S.p.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A clodronate dose will be considered as effective when a ≥ 8.5 mm reduction in the VAS of knee pain will be observed at Week 7 vs. Placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean changes in the VAS of knee pain observed at each other visit than Week 7 vs. Placebo and vs Baseline., Mean changes in the VAS of knee pain observed 120 minutes after IA injection at Baseline, Weeks 1, 2 and 3 vs predose assessment., Mean changes in the Lequesne Algo-functional Index at each visit vs Placebo and vs Baseline., Mean changes in the WOMAC Index at each visit vs Placebo and vs Baseline., Mean changes in the Range of Motion at each visit vs Placebo and vs Baseline., Use of rescue drug consumption (paracetamol) across the patients visits. | — |
Countries
Italy
Outcome results
None listed