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

Primary Purpose

Osteoarthritis of the Knee

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

TV-45070

Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, OA, Arthritis pain

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

TV-45070 4%

TV-45070 8%

Placebo

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The five items in the WOMAC Pain Subscale cover pain during walking, using stairs, in bed, sitting or lying, and standing. Daily WOMAC pain subscale score is calculated as the sum of the 5-item pain subscale scores (WOMAC) recorded at evening for a total range of 0 (no pain) to 500 (worst pain on all 5 items). 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 scores for the 5-item pain subscale as a covariate; and patient as a random factor.

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)

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]). The possible score for each item ranges from 0 (no pain) to 100 mm (worst pain). 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. 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 morning WOMAC Question 1 score as a covariate; and patient as a random factor.

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

The seventeen items in the WOMAC physical function subscale cover stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. WOMAC physical function subscale score is calculated as the sum of the 17-item physical function subscale scores (WOMAC) for a total range of 0 (no pain) to 1700 (worst pain on all 17 items). Negative change from baseline scores indicate improvement in pain. MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline physical function WOMAC scores for the 17-item subscale as a covariate; and patient as a random factor.

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

The two items in the WOMAC stiffness subscale cover stiffness after first waking and later in the day. WOMAC stiffness subscale score is calculated as the sum of the 2-item stiffness subscale scores (WOMAC) for a total range of 0 (no stiffness) to 200 (worst stiffness on both items). Negative change from baseline scores indicate improvement in stiffness. MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline stiffness WOMAC scores for the 2-item subscale as a covariate; and patient as a random factor.

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

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). Average pain is calculated using a MMRM which 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. Responder rate was calculated as 100 * the value of (average WOMAC pain subscale during the last 5 days of treatment [Days 24 to 28]) - average WOMAC pain subscale at baseline [the 5 days prior to randomization])/average WOMAC pain subscale at baseline (the 5 days prior to randomization). Participants with missing responder rates were treated as nonresponders.

Change From Baseline (Randomization Visit) to the Week 4 Visit in the Pain Quality Assessment Scale - Revised (PQAS-R) for the Target Knee Using a Mixed Model for Repeated Measures

PQAS-R is a standardized self-report tool that measures various aspects of a participant's pain. There are 19 questions (question 19 has 2 parts) that ask the participant to rate the various aspects (intensity, sharpness, heat, cold, etc.) of his/her pain over the past week on average on a scale of 0 to 10 (0 = not [aspect] and 10 = the most or worst imaginable [aspect]). PQAS-R score at each visit is the sum of responses for the 19 questions for a total range of 0=no pain to 200=worst imaginable pain in all aspects. Negative change from baseline scores indicate improvement in stiffness. MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline PQAS-R score for the 19 questions (20 parts) as a covariate; and patient as a random factor.

Participants' Global Assess of Treatment as Measured by the Patient Global Impression of Change (PGIC) at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)

PGIC is a standardized self-report tool that measures the change in a participants overall status rating since the start of treatment on 7-point scale. The 7-point scale is defined as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. The MMRM model includes week, treatment, study center, and treatment by week interaction as the fixed factors and unconstructed variance-covariance structure.

Change From Baseline in the Patient Global Assessment (PGA) Scores at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)

PGA is a simple self-report tool for measuring the overall way arthritis is affecting the patient at a particular point in time. There is 1 question and the response is provided on a visual analog scale (VAS) from 0 (very poor) to 100 (very good). The question is: Considering all the ways your arthritis affect you, how are you feeling today? Positive change from baseline scores indicate improvement. The MMRM model includes week, treatment, study center, and treatment by week interaction as the fixed factors; baseline PGA score as a covariate and unconstructed variance-covariance structure.

Percentage of Participants Who Are Responders Per Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 4

Participants are classified as 'Yes' if the following criteria are met: - >=50% improvement from baseline and an absolute change >=20 on a scale of 1-100 in either the pain or physical function subscale (WOMAC). or 2 of the 3 criteria as below met: - 1) >=20% improvement from baseline and an absolute change >=10 on a scale of 1-100 in the pain subscale (WOMAC); - 2) >=20% improvement from baseline and an absolute change >=10 on a scale of 1-100 in the physical function subscale (WOMAC); - 3) at least a 20% improvement from baseline and an absolute change >=10 on a scale of 1-100 in PGA. Otherwise, 'No' The responder rate per OMERACT-OARSI criteria was analyzed using a generalized estimating equation (GEE) method, where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment*week as explanatory factors. The unstructured working correlation structure was applied.

Participants With Treatment-Emergent Adverse Events

An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

Full Information

NCT ID

NCT02068599

First Posted

February 19, 2014

Last Updated

November 5, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02068599

Brief Title

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

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (4% and 8% w/w Ointment) in Patients With Primary Osteoarthritis Affecting a Single Knee

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

April 14, 2014 (Actual)

Primary Completion Date

April 6, 2015 (Actual)

Study Completion Date

May 4, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

Keywords

Osteoarthritis, OA, Arthritis pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

389 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TV-45070 4%

Arm Type

Experimental

Arm Description

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.

Arm Title

TV-45070 8%

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

TV-45070

Other Intervention Name(s)

funapide, XEN402

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

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)

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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)

Description

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]). The possible score for each item ranges from 0 (no pain) to 100 mm (worst pain). 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. 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 morning WOMAC Question 1 score as a covariate; and patient as a random factor.

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Change From Baseline (Randomization Visit) to the Week 4 Visit in the Pain Quality Assessment Scale - Revised (PQAS-R) for the Target Knee Using a Mixed Model for Repeated Measures

Description

Time Frame

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

Title

Participants' Global Assess of Treatment as Measured by the Patient Global Impression of Change (PGIC) at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)

Description

Time Frame

Weeks 2 (day 15), 4 (day 29)

Title

Change From Baseline in the Patient Global Assessment (PGA) Scores at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)

Description

Time Frame

Baseline (day 1, predose), Week 2 (day 15) and Week 4 (day 29)

Title

Percentage of Participants Who Are Responders Per Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 4

Description

Time Frame

Week 4 (day 29)

Title

Participants With Treatment-Emergent Adverse Events

Description

Time Frame

day 1 up to day 57

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sr. Director, GCO, Theraputic Area Head

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 12217

City

Anaheim

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12244

City

Anaheim

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12252

City

Cerritos

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 13009

City

Cerritos

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12233

City

El Cajon

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12240

City

Lomita

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12251

City

Sacramento

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12234

City

Spring Valley

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12256

City

Clearwater

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12241

City

DeLand

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12246

City

Eustis

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12231

City

Fort Myers

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12216

City

Hialeah

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12230

City

Jacksonville

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12220

City

Miami

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12221

City

Oldsmar

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12226

City

Orlando

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12237

City

Orlando

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12255

City

Ormond Beach

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12225

City

Plantation

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12229

City

Sanford

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12235

City

Tampa

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12253

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 12250

City

Marietta

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 12243

City

Evansville

State/Province

Indiana

Country

United States

Facility Name

Teva Investigational Site 12238

City

Overland Park

State/Province

Kansas

Country

United States

Facility Name

Teva Investigational Site 12218

City

New Orleans

State/Province

Louisiana

Country

United States

Facility Name

Teva Investigational Site 12245

City

Watertown

State/Province

Massachusetts

Country

United States

Facility Name

Teva Investigational Site 12228

City

Bingham Farms

State/Province

Michigan

Country

United States

Facility Name

Teva Investigational Site 12242

City

Hazelwood

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 12249

City

Saint Louis

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 12223

City

Omaha

State/Province

Nebraska

Country

United States

Facility Name

Teva Investigational Site 12219

City

New York

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 12239

City

Charlotte

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 12248

City

Raleigh

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 12247

City

Winston-Salem

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 12254

City

Winston-Salem

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 12224

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 12236

City

Memphis

State/Province

Tennessee

Country

United States

Facility Name

Teva Investigational Site 12232

City

Dallas

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 12227

City

Plano

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 12222

City

Charlottesville

State/Province

Virginia

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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

Osteoarthritis of the Knee

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial