A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis Knee Pain

NCT03081806 | Completed Phase 3 FDA Drug

• 1 other identifier: TF-X0002-31
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 33

Brief Summary

This is 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 pain of subjects with Osteoarthritis of the Knee.

Conditions

Pain Associated With Osteoarthritis of the Knee

Keywords

Phase 3; Efficacy; Safety; Osteoarthritis, Knee, Pain

Outcome Measures

Primary Outcomes (1)

• WOMAC pain subscale score in the target knee at Week 12 compared to Baseline

  To evaluate the effect of X0002 spray compared to placebo for relief of knee pain in subjects with OA of the knee as measured by the WOMAC pain subscale score in the target knee at Week 12.

  Week 12

Secondary Outcomes (7)

• Subject's Global Assessment of Disease Status at Week 12.

  Week 12 of treatment

• WOMAC fuctional subscale score in the target knee at Week 12

  Week 12 of treatment

• WOMAC (NRS) pain subscale in the target knee at Week 2, 4, 8, and 22

  Week 2, 4, 8 , and 22 of treatment

• WOMAC function subscale score

  Week 2, 4, 8 , and 22 of treatment

• Average eDiary daily (NRS) score in the target knee

  Week 2, 4, 8, 12 and 22 of treatment

Study Arms (2)

Group A

EXPERIMENTAL

High dose group: X0002, BID (approximately every 12 hours; n=102); Placebo, BID(approximately every 12 hours; n=102)

Drug: X0002

Group B

PLACEBO COMPARATOR

Low dose group: X0002, BID (approximately every 12 hours; n=102); Placebo, BID(approximately every 12 hours; n=102)

Drug: X0002

Interventions

X0002 DRUG

Subjects will complete 22 weeks of double-blind treatment and then enter into 30 weeks open-label treatment.

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:

• Ability to read and 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.
• An understanding, ability, and willingness to fully comply with study procedures and restrictions.
• Subject must be a male or female between 35 and 85 years of age, inclusive.
• Female subjects must either not be of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\]) or be willing to Practice at least 1 of the following medically acceptable methods of birth control.
• Subject must have a body mass index (BMI) between 18.5 and 45 kg/m2, inclusive.
• Must have a history of clinically symptomatic OA of the knee for ≥6 months.
• Must meet the American College of Rheumatology clinical classification criteria for knee OA. These criteria include the presence of knee pain in addition to at least 3 of the following 6 items:
• age of ≥50 years
• stiffness lasting \<30 minutes
• crepitus on knee motion
• Bony Tenderness
• Bony Enlargement
• No palpable warmth
• A subject must have a Kellgren Lawrence Grade of 2,3 or 4 as determined by a central radiologist at the first screening visit. .
• Subject must have had knee pain while standing, walking, and/or in motion for at least 14 days during the month prior to Screening.

You may not qualify if:

• Has worker's compensation injuries affecting the knee or back.
• Has a history of or is currently in litigation regarding joint injuries.
• Has secondary OA of the target knee or OA of lower limb joints other than the knee that, in the investigator's opinion, could interfere with pain and functional assessments related to the target knee.
• Has a history of total or partial knee replacement, arthroplasty, or other knee surgery on the target knee.
• In the investigator's opinion, has had significant injury involving the target knee within the 6 months before Screening.
• Has skin lesions or wounds on or near the target knee at Screening or at Baseline (Day 1) that, in the investigator's opinion, would affect absorption of the medication.
• Has used opiates (including tramadol or tapentadol) or systemic corticosteroids within 30 days before Screening or requires treatment with chronic opiates or systemic corticosteroids.
• Subjects with a placebo response exceeding 25% improvement in the average Western Ontario and McMaster Osteoarthritis Index \[WOMAC\] pain subscale score from Screening Visit to Day 1 will be excluded.
• 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 intra articular (IA) injections of corticosteroids, hyaluronic acid, or viscosupplements (e.g., Synvisc®) to the target knee within the 12 weeks before Screening
• Has had IA or intravenous (IV) stem cell therapy in the 6 months prior to Screening
• Is receiving or is planning to receive concomitant nonpharmacologic treatments (e.g., physiotherapy, acupuncture) that in the investigator's opinion could confound efficacy assessments within 14 days of Day 1.
• Has a history of significant hypersensitivity, intolerance, or allergy to ibuprofen or any other NSAIDs, aspirin, or acetaminophen.
• Has had an active gastrointestinal (GI) ulceration in the 6 months prior to Screening or a history of GI bleeding within 5 years of Screening.
• Has used an anticoagulant or antiplatelet agent (except aspirin up to 325 mg/day for cardiac prophylaxis) in the 30 days prior to Screening.

Sponsors & Collaborators

• Techfields Pharma Co. Ltd: lead

Study Sites (33)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Yuma Clinical Trials

Yuma, Arizona, 85364, United States

Location

Orange County Research Institute

Anaheim, California, 92801, United States

Location

Biosolutions Clinical Research Center

La Mesa, California, 91942, United States

Location

Velocity Clinical Research

North Hollywood, California, 91606, United States

Location

University Clinical Research-Deland

DeLand, Florida, 32720, United States

Location

Reliable Clinical Research

Hialeah, Florida, 33012, United States

Location

Health Awareness Inc.

Jupiter, Florida, 33458, United States

Location

Ascension Research

Pinellas Park, Florida, 33781, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Horizon Clinical Research

Newnan, Georgia, 30263, United States

Location

Pinnacle Trials Inc

Stockbridge, Georgia, 30281, United States

Location

Chicago Clinical Research Institute Inc

Chicago, Illinois, 60607, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Healthcare Research Network

Flossmoor, Illinois, 60422, United States

Location

Affinity Health Corp

Oak Brook, Illinois, 60523, United States

Location

DelRicht Research

New Orleans, Louisiana, 70124, United States

Location

DelRicht Research

Prairieville, Louisiana, 70769, United States

Location

DelRicht Research - Gulfport

Gulfport, Mississippi, 39501, United States

Location

Healthcare Research Network, LLC

Hazelwood, Missouri, 63042, United States

Location

AMR Kansas City

Kansas City, Missouri, 64114, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

AMR: Las Vegas

Las Vegas, Nevada, 89119, United States

Location

Upstate Clinical Research Associates LLC

Williamsville, New York, 14221, United States

Location

Aventiv Research, Inc - Brice Road Location

Columbus, Ohio, 43213, United States

Location

DelRicht Research

Tulsa, Oklahoma, 74133, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

Clinical Investigations of Texas

Plano, Texas, 75075, United States

Location

Quality Research Inc.

San Antonio, Texas, 78209, United States

Location

Wasatch Clinical Research LLC

Salt Lake City, Utah, 84107, United States

Location

Charlottesville Medical Research, LLC

Charlottesville, Virginia, 22911, United States

Location

Spectrum Medical, Inc

Danville, Virginia, 24541, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chongxi Yu, PhD

  Techfields Inc

  STUDY CHAIR

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: March 16, 2017
• Study Start: September 24, 2021
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (33)