Study to Evaluate Resiniferatoxin in Patients With Knee Osteoarthritis Whose Total Knee Replacement Surgery is Delayed
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|ClinicalTrials.gov Identifier: NCT04386980|
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : June 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee Osteo Arthritis Knee Knee Pain Chronic||Drug: Resiniferatoxin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3, Randomized, Multi-center, Blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intra-articular Resiniferatoxin Versus Placebo to Manage Pain in Patients With Osteoarthritis of the Knee Whose Total Knee Replacement Surgery is Delayed|
|Estimated Study Start Date :||August 2020|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
12.5 ug of Resiniferatoxin in 5 mL volume administered once intra-articularly
Resiniferatoxin is a compound purified from natural sources.
Other Name: RTX
Placebo Comparator: Placebo
5 mL of diluent in normal saline administered once intra-articularly
Diluent in normal saline
- Change in WOMAC pain and function subscales combined score [ Time Frame: Baseline to Week 12 ]Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 3.1 numerical rating scale (NRS) [0-10 scale] Pain and Function combined score. The combined score ranges from 0 to 220; a higher score indicates greater severity of disease.
- Safety of RTX: Incidence and severity of adverse events [ Time Frame: Baseline through Week 12 ]Incidence and severity of adverse events
- Change in analgesic usage [ Time Frame: Baseline to Week 4, Week 8, Week 12 ]Change in analgesic medication usage as reported by subjects
- Change in WOMAC pain and function subscales combined score [ Time Frame: Baseline to Week 4, Week 8 ]Change in the WOMAC 3.1 NRS [0-10 scale] Pain and Function combined score. The combined score ranges from 0 to 220; a higher score indicates greater severity of disease.
- Patient Global Impression of Change (PGIC) in index knee pain [ Time Frame: Baseline to Week 4, Week 8, Week 12 ]Rating of change in index knee pain using the 7-point PGIC scale where 1 = very much improved and 7 = very much worsened.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386980
|Study Director:||Monica Luchi, MD||Sorrento Therapeutics, Inc.|