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A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis of the Lumbar Spine

NCT03110523 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-06-12

No results posted yet for this study

Summary

This is a Phase 3, Multicenter, Randomized, 22 Week, Double-Blind, Placebo Controlled and 3-Week, Open-Label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of the signs and symptoms of Subjects with Osteoarthritis of the Lumbar Spine. To evaluate the efficacy of X0002 spray compared to placebo for the relief of low back pain disability in subjects with osteoarthritis (OA) of the low back.

Conditions

  • Osteoarthritis of the Lumbar Spine
  • Pain, Back

Interventions

DRUG

X0002

All subjects who provide informed consent will initiate the Screening Period of at least 14 (±3) days for the assessment of eligibility including radiographic evaluation of the lumbar spine. X-ray images must be collected within 4-11 hours after the subject wakes up. Those subjects who meet preliminary eligibility criteria will be treated with placebo in a subject-blind manner for 14(±3) days from Screening Visit to Day 1. Subjects with a placebo response exceeding 25% improvement in the average NPRS score over the previous 7 days will be excluded. Subjects with a Lane grading of 1 or 2 on their neutral lateral lumbar spine film per the central radiologist are eligible to be enrolled. At Day 1, eligible subjects will be randomly assigned to 1 of 2 treatment groups in a 1:1 ratio with a 1:1 ratio of active:placebo within each treatment group, and stratified evenly according to Lane Radiographic Grading Scale summary score (1 or 2) and gender.

Sponsors & Collaborators

  • Techfields Pharma Co. Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2024-07-30
Completion
2025-07-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03110523 on ClinicalTrials.gov