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:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT06917404
Brief Summary:
The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee OA pain.
Study details include:
* The study duration will be up to 64 weeks.
* The treatment duration will be 6 weeks.
* The visit frequency will be twice weekly during treatment.
* The visit/contact frequency will be every 4-6 weeks during the 52-week Follow-up period.
* Approximately 466 participants will be enrolled into this study.
Detailed Description:
This is a randomised, double-blind, placebo-controlled, multicenter study that will evaluate the dose and treatment effect of PPS in participants with knee OA pain.
Participants will be randomised 1:1 to receive twice-weekly subcutaneous (SC) injections of 2 mg/kg PPS or placebo for 6 weeks.
An interim analysis for a potential early conclusion is planned after approximately 50% of participants complete Day 112.
The primary analysis will be conducted when all participants complete Day 112. A final analysis will be conducted when the last participant reaches Day 404.
The maximum duration for each participant is up to 64 weeks, which includes
* 7-week Screening Period from Day -45 to Day -1
* 6-week Treatment Period from Day 1 to Day 39
* 52-week Follow-up Period from Day 40 to Day 404
Study:
NCT06917404
Study Brief:
Protocol Section:
NCT06917404