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Placebo-controlled Phase 2b Study of Safety and Efficacy of XT-150 in Osteoarthritis of the Knee

2019-10-17 11:03:44 | BioPortfolio

Summary

This is a Phase 2 safety and efficacy study of XT-150 in adult participants experiencing moderate to severe pain due to osteoarthritis of the knee.

Description

This is a Phase 2 safety and efficacy study of XT-150 in adult participants experiencing moderate to severe pain due to osteoarthritis of the knee.

Baseline confirmation of study eligibility will be completed the day before or day of study drug administration.

Study drug will be administered by intra-articular (IA) injection into the joint space of the knee.

Up to 270 participants will be randomly enrolled into 1 of 3 treatment groups (90 participants/ group). Treatment Groups:

1. Placebo (1 mL)

2. Low dose XT-150 (1 mL)

3. High dose XT-150 (1 mL)

The study will be conducted in 2 stages, A and B:

A. Placebo-controlled for 6 months

B. Continued follow up for 6 months with the option of receiving one of two doses of XT-150 injection to the index knee.

Final assessments will be 12 months after the first IA dose.

Study Design

Conditions

Osteoarthritis, Knee

Intervention

XT-150

Location

Neurovations (Napa Pain Institute)
Napa
California
United States
94558

Status

Not yet recruiting

Source

Xalud Therapeutics, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-17T11:03:44-0400

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