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

NCT02067611 | Completed Phase 2 Results DMC

• 1 other identifier: TF-X0002-21
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 20

Brief Summary

This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee. Objectives of the study:

1. 1.To evaluate the efficacy of X0002 spray compared to placebo for relief of knee pain in subjects with osteoarthritis (OA) of the knee;
2. 2.To assess the safety and tolerability of multiple doses of X0002 when administered as a topical spray.

Conditions

Osteoarthritis of the Knee

Keywords

Phase 2, Efficacy, Safety, Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• To Evaluate the Efficacy of X0002 Spray Compared to Placebo for Relief of Knee Pain in Subjects With Osteoarthritis (OA) of the Knee

  The Primary Efficacy Endpoint is change from Baseline in the WOMAC (VAS) pain subscale score for the target knee at 4 weeks of treatment, and will be analyzed using an analysis of covariance (ANCOVA). Treatment will be included as a fixed class effect and WOMAC Baseline pain subscale score as covariates. The primary comparisons of interest will be the difference between active Group A (low dose) and combined placebo, active Group B (middle dose) and combined placebo, and active Group C (high dose) and combined placebo. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned.

  4 weeks of treatment

Secondary Outcomes (4)

• To Assess the Safety and Tolerability of Multiple Doses of X0002 When Administered as a Topical Spray

  2, 8, and 12 weeks of treatment

• To Evaluate the Effect of X0002 Spray Compared to Placebo for the Relief of Joint Stiffness

  2, 4, 8, and 12 weeks of treatment

• To Assess the Effect of X0002 Spray Compared to Placebo on Difficulty Performing Daily Activities

  at 2, 4, 8, and 12 weeks of treatment

• Characterize the Pharmacokinetics of X0002

  at the Week 2, week 3, week 4 and Week 12

Other Outcomes (6)

• Subject's Global Assessment of Disease Status of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment

  at 2, 4, 8, and 12 weeks of treatment

• Investigator's Global Assessment of Disease Status of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment

  at 2, 4, 8, and 12 weeks of treatment

• Subject's Global Assessment of Response to Therapy of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment

  at 2, 4, 8, and 12 weeks of treatment

Study Arms (2)

X0002

EXPERIMENTAL

low dose, BID;middle dose, BID, or high dose, BID.

Drug: X0002

Placebo

PLACEBO COMPARATOR

low dose, BID; middle dose, BID, or high dose, BID.

Drug: Placebo

Interventions

X0002 DRUG

Parallel Assignment

Also known as: Active drug

X0002

Placebo DRUG

Parallel Assignment

Also known as: Placebo powder

Placebo

Eligibility Criteria

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

You may qualify if:

• A subject must be a male or female between 35 and 85 years of age, inclusive.
• A subject must have a body mass index (BMI) between 18.5 and 39.9 kg/m2, inclusive.
• A subject must have a diagnosis of idiopathic OA according to the American College of Rheumatology (ACR) clinical and radiographic criteria (knee pain, osteophytes, and at least one of the following: \>50 years of age, morning stiffness lasting \<30 minutes after getting up in the morning, or crepitus).
• A subject must have a Kellgren Lawrence Grade of 1 or 2 as determined by the Investigator or a local radiologist at Screening.
• A subject must have a history of clinically symptomatic mild to moderate OA of the knee for ≥6 months.
• A subject must have had knee pain while standing, walking, and/or on motion for at least 14 days during the month prior to Screening.
• A subject must have a knee pain score ≥40 mm and \<90 mm on a 100 mm VAS (with or without analgesic medication) on at least 10 of the 14 days prior to randomization.
• A subject must be willing to discontinue any NSAIDs or other analgesic (eg, aspirin, acetaminophen) or potentially confounding concomitant treatments (eg, physiotherapy, acupuncture) starting 4 days before the administration of the first dose of study medication until completing participation in the study. (The use of ≤325 mg acetylsalicylic acid per day as cardiac prophylaxis is permitted.) The subject will be allowed to take rescue medication (acetaminophen) for pain during the study except during the 24 hours prior to Baseline (Day1), Week 2, Week 4, Week 8, Week 12/EOS, and Follow-up assessments.
• A subject must be willing to avoid unaccustomed physical activity (eg, starting a new weight lifting routine) for the duration of the study.

You may not qualify if:

• A subject who has secondary OA of the knee or OA of lower limb joints other than the knee that, in the opinion of the Investigator, could interfere with pain and functional assessments related to the knee
• A subject who has OA of the knee with a Kellgren Lawrence Grade ≥3 as determined by the Investigator or a local radiologist at Screening
• A subject who has a history of total or partial knee replacement, arthroplasty, or other knee surgery on either knee
• A subject who has had significant injury, as judged by the Investigator, involving the target knee within the 6 months before Screening.
• A subject who has skin lesions or wounds on or near the knees to be treated at Screening or on Day 1 prior to the first administration of study medication
• A subject who has used opiates or corticosteroids within 30 days before Screening or who requires treatment with chronic opiates or corticosteroids
• A subject who has had intra articular injections of corticosteroids, hyaluronic acid, or viscosupplements (eg, Synvisc®) to a knee to be treated within the 3 months before Screening.
• A subject who has a history of significant hypersensitivity, intolerance, or allergy to ibuprofen, any NSAIDs, aspirin, or acetaminophen
• A subject who has had an active peptic ulceration in the 12 months prior to Screening or a history of gastrointestinal (GI) bleeding within 5 years of Screening
• A subject who has used an anticoagulant (except aspirin up to 325 mg/day for cardiac prophylaxis) in the month prior to Screening
• A subject who has positive results on fecal occult blood testing at Screening or on Day 1 prior to the first administration of study medication
• A subject who has a history of chronic inflammatory disease (such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis), fibromyalgia, conditions that may affect the target joint (eg, osteonecrosis, chondrocalcinosis), or asthma.

Sponsors & Collaborators

• Lina Xu: lead

Study Sites (20)

Fiel Family & Sports Medicine/Clinical Research Advantage Inc

Tempe, Arizona, 85283-1528, United States

Location

Med Center

Carmichael, California, 95608, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

New England Research Assoc.

Trumbull, Connecticut, 06611, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 32720, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Health Awareness Inc.

Jupiter, Florida, 33458, United States

Location

Suncoast Clinical Research, Inc

New Port Richey, Florida, 34652, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

Clinical Trials Technology(CTT) Consultants, Inc.

Prairie Village, Kansas, 66206-1362, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042-1755, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141-7068, United States

Location

New Mexico Clinical Research & Osteoporosis Center, Inc.

Albuquerque, New Mexico, 87106, United States

Location

Hightop Medical Research

Cincinnati, Ohio, 45224, United States

Location

Prestige Clinical Research, LLC

Franklin, Ohio, 45005, United States

Location

Heritage Valley Medical Group

Beaver, Pennsylvania, 15009, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Quality Research Inc

San Antonio, Texas, 78209, United States

Location

Health Research of Hampton Roads, Inc

Newport News, Virginia, 23606, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Bulk Drugs

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Chongxi Yu
• Organization: Techfields

chongxiyu@hotmail.com

571 276 5371

Study Officials

• Chongxi Yu, Ph.D.

  Techfields Inc

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice president

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 20, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: April 1, 2016
• Last Updated: February 7, 2018
• Results First Posted: February 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)