A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee

NCT02068599 | Completed Phase 2 Results

• 1 other identifier: TV-45070-CNS-20005
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 42

Brief Summary

The primary purpose of the study is to evaluate the change from baseline after 4 weeks of topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief of symptoms of primary OA affecting a single knee

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis; OA; Arthritis pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Last 5 Days of Treatment in the Average Evening Pain Intensity In the Target Knee When Walking on a Flat Surface Using a Mixed Model for Repeated Measures (MMRM)

  The Western Ontario and McMasters Universities Arthritis Index \[WOMAC\] is a widely used, validated, patient-reported questionnaire used to assess pain, stiffness, and physical function in patients with OA of the knee. It consists of 24 items separated into 3 domains (pain \[5 items\], stiffness \[2 items\], and physical function \[17 items\]). WOMAC Question 1 is the first question in the pain domain and asks patients to rate their pain in the target knee while walking on a flat surface. The possible score for each item ranges from 0 (no pain) to 100 mm (worst pain). Participants record their response to WOMAC Question 1 in the study diary based on average pain upon walking since the last assessment or over the past 12 hours. Negative change from baseline scores indicate improvement in pain. MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline average evening WOMAC Question 1 score as a covariate; and patient as a random factor.

  Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)

Secondary Outcomes (10)

• Change From Baseline to Last 5 Days of Treatment in the Average Daily WOMAC Pain Subscale Score In the Target Knee Using a Mixed Model for Repeated Measures

  Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)

• Change From Baseline to Last 5 Days of Treatment in the Average Morning Pain Intensity In the Target Knee When Walking on a Flat Surface Using a Mixed Model for Repeated Measures (MMRM)

  Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)

• Change From Baseline (Randomization Visit) to the Week 4 Visit in the WOMAC Physical Function Subscale Score for the Target Knee Using a Mixed Model for Repeated Measures

  Baseline (day 1, predose), Treatment: Week 4 (day 29)

• Change From Baseline (Randomization Visit) to the Week 4 Visit in the WOMAC Stiffness Subscale Score for the Target Knee Using a Mixed Model for Repeated Measures

  Baseline (day 1, predose), Treatment: Week 4 (day 29)

• Percentage of Participants With a >=30% and a >=50% Response in Average Evening Pain Intensity of WOMAC Question 1 in the Target Knee During the Last 5 Days of Treatment Compared With Baseline

  Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)

Study Arms (3)

TV-45070 4%

EXPERIMENTAL

TV-45070 ointment in a 4% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.

Drug: TV-45070

TV-45070 8%

EXPERIMENTAL

TV-45070 ointment in a 8% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.

Drug: TV-45070

Placebo

PLACEBO COMPARATOR

Placebo ointment applied topically twice daily to the target knee during the treatment period from day 1 through day 28.

Drug: Placebo

Interventions

TV-45070 DRUG

TV-45070 ointment administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.

Also known as: funapide, XEN402

TV-45070 4%; TV-45070 8%

Placebo DRUG

Placebo ointment matching active intervention administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is between 40 and 85 years of age, Patient has primary OA in a single knee (target knee) confirmed by American College of Rheumatology criteria.
• For patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics at the time of the screening visit,
• Patient has visual analog scale (VAS) pain scores with acceptable ranges as determined by the investigator during screening
• Except for OA, patient is judged by the investigator to be medically healthy and able to participate in the study.
• Other criteria apply, please contact the investigator for additional information

You may not qualify if:

• Patient has secondary or inflammatory arthritis of the knee such as psoriasis, rheumatoid arthritis (RA), gout, other primary bone disease, or acute trauma.
• Patient has symptomatic chondrocalcinosis
• Patient has a history of fibromyalgia.
• Patient has any painful or disabling conditions that in the opinion of the investigator may confound assessment of pain scoring.
• Patient has uncontrolled cardiac, renal, hepatic or other systemic disorders that in the opinion of the investigator may jeopardize the patient.
• Patient has significant edema or skin disorder (including sores, rashes, or ulcers) at the target knee and surrounding area.
• Patient has a history of total or partial knee replacement in either leg.
• Patient had a major reconstructive knee surgery or arthroscopy of the target knee within 6 months before the screening visit.
• Patient is unable or unwilling to discontinue opioid and/or other prescription analgesics for control of OA pain.
• Patient is intolerant to study drug, its excipients, and/or acetaminophen.
• Patient uses any over the counter oral medications such as glucosamine or chondroitin sulfate products, unless the patient has been receiving the medication for ≥3 months at the time of the screening visit and maintains the medication as stable therapy for the duration of the study.
• Other criteria apply, please contact the investigator for additional information

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (42)

Teva Investigational Site 12217

Anaheim, California, United States

Location

Teva Investigational Site 12244

Anaheim, California, United States

Location

Teva Investigational Site 12252

Cerritos, California, United States

Location

Teva Investigational Site 13009

Cerritos, California, United States

Location

Teva Investigational Site 12233

El Cajon, California, United States

Location

Teva Investigational Site 12240

Lomita, California, United States

Location

Teva Investigational Site 12251

Sacramento, California, United States

Location

Teva Investigational Site 12234

Spring Valley, California, United States

Location

Teva Investigational Site 12256

Clearwater, Florida, United States

Location

Teva Investigational Site 12241

DeLand, Florida, United States

Location

Teva Investigational Site 12246

Eustis, Florida, United States

Location

Teva Investigational Site 12231

Fort Myers, Florida, United States

Location

Teva Investigational Site 12216

Hialeah, Florida, United States

Location

Teva Investigational Site 12230

Jacksonville, Florida, United States

Location

Teva Investigational Site 12220

Miami, Florida, United States

Location

Teva Investigational Site 12221

Oldsmar, Florida, United States

Location

Teva Investigational Site 12226

Orlando, Florida, United States

Location

Teva Investigational Site 12237

Orlando, Florida, United States

Location

Teva Investigational Site 12255

Ormond Beach, Florida, United States

Location

Teva Investigational Site 12225

Plantation, Florida, United States

Location

Teva Investigational Site 12229

Sanford, Florida, United States

Location

Teva Investigational Site 12235

Tampa, Florida, United States

Location

Teva Investigational Site 12253

Atlanta, Georgia, United States

Location

Teva Investigational Site 12250

Marietta, Georgia, United States

Location

Teva Investigational Site 12243

Evansville, Indiana, United States

Location

Teva Investigational Site 12238

Overland Park, Kansas, United States

Location

Teva Investigational Site 12218

New Orleans, Louisiana, United States

Location

Teva Investigational Site 12245

Watertown, Massachusetts, United States

Location

Teva Investigational Site 12228

Bingham Farms, Michigan, United States

Location

Teva Investigational Site 12242

Hazelwood, Missouri, United States

Location

Teva Investigational Site 12249

St Louis, Missouri, United States

Location

Teva Investigational Site 12223

Omaha, Nebraska, United States

Location

Teva Investigational Site 12219

New York, New York, United States

Location

Teva Investigational Site 12239

Charlotte, North Carolina, United States

Location

Teva Investigational Site 12248

Raleigh, North Carolina, United States

Location

Teva Investigational Site 12247

Winston-Salem, North Carolina, United States

Location

Teva Investigational Site 12254

Winston-Salem, North Carolina, United States

Location

Teva Investigational Site 12224

Cincinnati, Ohio, United States

Location

Teva Investigational Site 12236

Memphis, Tennessee, United States

Location

Teva Investigational Site 12232

Dallas, Texas, United States

Location

Teva Investigational Site 12227

Plano, Texas, United States

Location

Teva Investigational Site 12222

Charlottesville, Virginia, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

TV-45070

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Sr. Director, GCO, Theraputic Area Head

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 21, 2014
• Study Start: April 14, 2014
• Primary Completion: April 6, 2015
• Study Completion: May 4, 2015
• Last Updated: November 9, 2021
• Results First Posted: October 23, 2018

Record last verified: 2021-11

Locations

US (42)