Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT01113333
Brief Summary:
Primary Objective:
* Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis.
Secondary Objective:
* Assess systemic exposure of SAR113945 following intra-articular delivery.
Detailed Description:
The total study duration per subject ranges from 4 to 20 weeks broken down as follows:
* screening within 4 weeks before dosing,
* follow-up of 4 weeks (28 days) after the single dose of study medication,
* prolonged by a maximum of 12 weeks if plasma PK level \> Limit Of Quantification (LOQ) at Day 28.
Study:
NCT01113333
Study Brief:
Protocol Section:
NCT01113333