NCT03110523

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

A Phase 3, Multicenter, 22-Week, Double-Blind and 30-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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Techfields Pharma Co. Ltd · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 Numeric Pain Rating Scale (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 Baseline (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 (i.e., 1 subject to active treatment and 1 subject to placebo), and stratified evenly according to Lane Radiographic Grading Scale summary score (1 or 2) and gender. Low back pain intensity as assessed by the average of the NPRS scores recorded in the eDiary for the 7 days prior to the visit will be used for the primary efficacy endpoint as well as secondary efficacy endpoints. Efficacy assessments will be conducted at Screening, and at visits at Day 1 (Baseline) Week 2, Week 4, Week 8, Week 12, Week 22, Week 32, Week 42, and Week 52 (EOT). The patient reported outcomes of Oswestry Disability Index (ODI), Subject Global Assessment, modified Brief Pain Inventory (mBPI) Severity score, mBPI Interference Score, Subject's Clinical Global Impression of Improvement (CGI-I), and Short Form 36-item Health Survey (SF-36) will be used for the secondary or exploratory efficacy endpoints. Safety assessments will be performed at each scheduled visit and will include assessment of AEs, vital signs (blood pressure, pulse rate, respiratory rate, and oral temperature), clinical laboratories, physical examination, skin irritation, and electrocardiograms (ECGs) as indicated in the schedule of events. Phone calls will be made to the subject by a qualified staff member at the site every 2 weeks between scheduled visits where applicable to collect additional information related to AEs.

Conditions

• Osteoarthritis of the Lumbar Spine
• Pain, Back

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-30
• Primary completion: 2024-07-30
• Completion: 2025-07-30
• First posted: 2017-04-12
• Last updated: 2023-06-12

Regulatory

• FDA-regulated drug study