Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263517
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-01-30
Brief Title:
Clinical Trial to Assess Efficacy Tolerability of Rising Doses of Clodronate in Painful Knee Osteoarthritis Patients
Sponsor:
SPA Società Prodotti Antibiotici SpA
Organization:
SPA Società Prodotti Antibiotici SpA
Study Overview
Official Title:
Adaptative Multicenter Randomized Double-blind Parallel-group Placebo Controlled Clinical Trial on the Efficacy and Tolerability of Different Escalating Doses of Intra-articular Clodronate in Patients With Painful Knee Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to to clarify which is the best dose of administration to select a dose and to confirm the therapeutic efficacy of clodronate in patients with painful knee osteoarthritis OA The clinical trial will be divided in two parts
The main questions it aims to answer are
in Phase II to assess the safety and tolerability of different escalating doses of intra articular IA clodronate
in Phase II to set a defined therapeutic dose DTD to be used in Phase III
in Phase III to assess the safety and tolerability of different escalating doses of IA clodronate to confirm and extensively evaluate the therapeutic efficacy and safety of the clodronate DTD in patients with knee OA
The main questions it aims to answer are
in Phase II to assess the safety and tolerability of different escalating doses of intra articular IA clodronate
in Phase II to set a defined therapeutic dose DTD to be used in Phase III
in Phase III to assess the safety and tolerability of different escalating doses of IA clodronate to confirm and extensively evaluate the therapeutic efficacy and safety of the clodronate DTD in patients with knee OA
Detailed Description:
The phase II will be a multicenter double-blind randomized placebo-controlled parallel group four-arm study according to the treatment dose dose finding
Briefly 4 groups of 74 patients in order to have 64 fully evaluated patients taking into consideration 10 patients dropped out ie a total of 296 patients with knee OA each will be randomly allocated to the following treatments
1 IA clodronate 2 mg2 ml once a week for 4 weeks total clodronate dose 8 mg
2 IA clodronate 5 mg2 ml once a week for 4 weeks total clodronate dose 20 mg
3 IA clodronate 10 mg2 ml once a week for 4 weeks total clodronate dose 40 mg
4 Placebo 2 ml once a week for 4 weeks total clodronate dose 0 mg
At the end of phase II the minimum effective clodronate dose will be selected as DTD for the Phase III
The phase III will be a multicenter double-blind randomized placebo-controlled two parallel groups DTD vs placebo study
Briefly patients with knee OA will be randomly assigned to two experimental groups
1 the DTD defined during the Phase II
2 Matching placebo The sample size of Phase III will be definitively calculated according to the extent of pain Visual Analogue Scale VAS reduction observed in the Phase II
Briefly 4 groups of 74 patients in order to have 64 fully evaluated patients taking into consideration 10 patients dropped out ie a total of 296 patients with knee OA each will be randomly allocated to the following treatments
1 IA clodronate 2 mg2 ml once a week for 4 weeks total clodronate dose 8 mg
2 IA clodronate 5 mg2 ml once a week for 4 weeks total clodronate dose 20 mg
3 IA clodronate 10 mg2 ml once a week for 4 weeks total clodronate dose 40 mg
4 Placebo 2 ml once a week for 4 weeks total clodronate dose 0 mg
At the end of phase II the minimum effective clodronate dose will be selected as DTD for the Phase III
The phase III will be a multicenter double-blind randomized placebo-controlled two parallel groups DTD vs placebo study
Briefly patients with knee OA will be randomly assigned to two experimental groups
1 the DTD defined during the Phase II
2 Matching placebo The sample size of Phase III will be definitively calculated according to the extent of pain Visual Analogue Scale VAS reduction observed in the Phase II
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-003124-33 | EUDRACT_NUMBER | None | None |