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

NCT03110523 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: TF-X0002-32
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Osteoarthritis, Lumbar Spine; Pain

Outcome Measures

Primary Outcomes (1)

• Average daily Numeric Pain Rating Scale (NPRS) score [0 (no pain) to 10 (worst pain imaginable] for the 7 days prior to Week 12

  Change from Baseline in the average daily NPRS score for the 7 days prior to Week 12

  Week 12

Secondary Outcomes (8)

• Average daily Numeric Pain Rating Scale (NPRS) score [0 (no pain) to 10 (worst pain imaginable] for the 7 days prior to Weeks 2, 4, 8, and 22

  Week 2, 4, 8, and 22

• Oswestry Disability Index (ODI) score ( 0 is equated with no disability and 100 is the maximum disability possible) at Weeks 2, 4, 8, 12, and 22

  Week 2, 4, 8, 12, and 22

• Subject Global Assessment of disease status at Weeks 2, 4, 8, 12, and 22

  Week 2, 4, 8, 12, and 22

• Modified Brief Pain Inventory (mBPI)-Severity score (on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine) at Weeks 2, 4, 8, 12, and 22

  Week 2, 4, 8, 12, and 22

• Modified Brief Pain Inventory (mBPI)-Interference score (on a scale ranging from 0 to 10 assessing how pain has interfered with certain functions in the previous 24 hours; '0=Does not interfere and 10=Completely interferes) at Weeks 2, 4, 8, 12, and 22

  Week 2, 4, 8, 12, and 22

Study Arms (2)

Group A

EXPERIMENTAL

High Dose: X0002 or placebo, BID (in the morning and before going to bed), n=376

Drug: X0002

Group B

EXPERIMENTAL

Low Dose: X0002 or placebo, BID (in the morning and before going to bed), n=376

Drug: X0002

Interventions

X0002 DRUG

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.

Also known as: X-0002

Group A; Group B

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to read and to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and applicable regulations, before completing any study related procedures.
• Has an understanding, ability, and willingness to fully comply with study procedures and restrictions, as determined by the investigator.
• Must be a male or female between 35 and 85 years of age, inclusive.
• Must have a body mass index between 18.5 and 40.0 kg/m2, inclusive.
• Must have a history (documented diagnosis) of clinically symptomatic OA of the lumbar spine for ≥3 months at Screening.
• Must have a Lane Radiographic Grading Scale summary score for lumbar spine OA (levels L1 through L5) of 1 or 2 as determined by a central radiologist at Screening.
• Must have had low back pain while standing, walking, and/or on motion for at least 14 days during the month prior to Screening per subject self-report documented by the investigator.
• Must have a score ≥4 and ≤9 on a 0 to 10 (11 point) NPRS (without analgesic medication other than rescue medication provided by the Sponsor) over the previous 7 days prior to Baseline (Day 1).
• Must have an ODI score ≥40% and ≤90 % at Screening Visit and Baseline (Day 1).
• With the exception of OA of the lumbar spine, must be in good general health with no clinically significant findings from medical history, vital signs, physical examination, ECG, and routine laboratory tests that could interfere with subject safety, pain or functional assessments, as determined by the investigator.
• Female subjects must either not be of childbearing potential defined as 1) postmenopausal for at least 1 year; follicle stimulating hormone \[FSH\] must be in postmenopausal range for the central lab if used to confirm postmenopausal status in a woman not using estrogen replacement therapy OR 2) surgically sterile \[i.e., bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\]) or be willing to practice abstinence or at least 1 of the following medically acceptable methods of birth control:
• Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before study drug administration;
• Intrauterine device;
• Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream).

You may not qualify if:

• \. Not willing to avoid unaccustomed, strenuous physical activity (e.g., starting a new weight lifting routine) for the duration of the study starting at Screening Visit and through their completion of participation in the study. Normal physical activity is allowed.
• Has an active or pending workman's compensation claim or litigation related to back pain.
• Has secondary OA of the low back or OA of lower limb joints that, in the opinion of the investigator, could interfere with pain and functional assessments related to the low back.
• Has a history of spinal surgery.
• Has more than 25% improvement from Numeric Pain Rating Scale (NPRS) score at the Screening visit to the average NPRS score over the previous 7 days prior to Day 1.
• Has had significant injury, as judged by the investigator, involving the back within the 6 months before Screening.
• Has been diagnosed with or has signs and symptoms of a radiculopathy, e.g., numbness or tingling in a dermatomal distribution of a lower limb, sciatica, as well as etiologies of low back pain other than OA.
• Has skin lesions or wounds on or near the lumbar spine area to be treated at Screening or on Day 1, which may influence absorption of the medication or confound safety assessments per the investigator's opinion.
• Has used gabapentin, pregabalin, antiepileptics, or specific antidepressants (i.e., tricyclics, serotonin norepinephrine reuptake inhibitors, or selective serotonin reuptake inhibitors) to treat pain in the 14 days before Screening. Other uses not related to the pain treatment may be permitted at the medical monitor's discretion provided they have been at a stable dose for at least 90 days.
• Has had injections of corticosteroids, botulinum toxin, or viscosupplements (e.g., Synvisc®) to the spine area (eg., intra articular \[IA\], epidural or paraspinal) within the 12 weeks before Screening.
• Has had IA, intradiscal or intravenous (IV) stem cell therapy in the 6 months prior to Screening.
• Has received concomitant non-pharmacologic treatments (e.g., physiotherapy, acupuncture) that per investigator opinion could confound efficacy assessments within 14 days of Day 1.
• Is not willing to discontinue any NSAIDs or other analgesics (i.e., acetaminophen other than rescue medication supplied by the Sponsor, and cyclooxygenase-2 \[COX-2\] inhibitors), other treatments such as cannabis, and any topical therapies (e.g., anesthetics, capsaicin) or potentially confounding concomitant nonpharmacologic treatments (e.g., physiotherapy, acupuncture) starting at Screening Visit until completing participation in the study (the use of ≤325 mg acetylsalicylic acid per day for cardiac prophylaxis is permitted).
• Is not willing to discontinue applying any topical preparations containing Vitamin A acids (including all trans retinoic acid \[tretinoin\], 13 cis retinoic acid \[isotretinoin\], 9 cis retinoic acid \[alitretinoin\], Vitamin A \[retinol\], retinal, and their derivatives) to the low back starting at Screening Visit until completing participation in the study. Topical preparations containing Vitamin A acids or retinol may be applied to areas of the skin above the shoulders or to the lower extremities.
• Has a history of significant hypersensitivity, intolerance, or allergy to ibuprofen, any other NSAIDs, aspirin, or acetaminophen.

Sponsors & Collaborators

• Techfields Pharma Co. Ltd: lead

MeSH Terms

Conditions

Osteoarthritis, Spine; Back Pain; Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: April 12, 2017
• Study Start: March 30, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2025
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share