A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

May 20, 2021 updated by: Biosplice Therapeutics, Inc.

A Phase 2, 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

This phase 2 study is a placebo-controlled, double-blind, parallel group study of four concentrations of SM04690 (0.03, 0.07, 0.15, and 0.23 mg per 2 mL injection) injected intraarticularly (IA) into the target knee joint of subjects with moderately to severely symptomatic osteoarthritis (OA). Based on previous studies of SM04690, key phenotypes of laterality (unilateral vs bilateral) as well as chronic pain (as measured by the Widespread Pain Index) were identified as confounding variables impacting the overall assessment of both radiologic and clinical efficacy outcomes. The design of SM04690-OA-04 is based upon previous study designs while assessing strategies to combat the confounding impact of laterality and chronic pain. To evaluate the effect of IA vehicle injection on patient-reported outcomes (PRO) such as pain, stiffness, and function in OA, this study also includes one cohort that receives a 2 mL IA injection of vehicle (placebo), and one cohort that receives a sham injection (i.e., a needle stick with 0 mL vehicle injected).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Research Site
      • Birmingham, Alabama, United States, 35216
        • Research Site
      • Mobile, Alabama, United States, 36608
        • Research Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Research Site
      • Phoenix, Arizona, United States, 85018
        • Research Site
      • Phoenix, Arizona, United States, 85053
        • Research Site
      • Tucson, Arizona, United States, 85712
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Canoga Park, California, United States, 91303
        • Research Site
      • Carmichael, California, United States, 95608
        • Research Site
      • Cerritos, California, United States, 90703
        • Research Site
      • El Cajon, California, United States, 92020
        • Research Site
      • Gold River, California, United States, 95670
        • Research Site
      • La Mesa, California, United States, 91942
        • Research Site
      • Los Angeles, California, United States, 90036
        • Research Site
      • Rancho Mirage, California, United States, 92270
        • Research Site
      • Sacramento, California, United States, 95817
        • Research Site
      • San Diego, California, United States, 92103
        • Research Site
      • San Marcos, California, United States, 92078
        • Research Site
      • Spring Valley, California, United States, 91978
        • Research Site
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Research Site
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Research Site
      • Trumbull, Connecticut, United States, 06606
        • Research Site
      • Waterbury, Connecticut, United States, 06708
        • Research Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • Research Site
      • Coral Gables, Florida, United States, 33134
        • Research Site
      • DeLand, Florida, United States, 32720
        • Research Site
      • Edgewater, Florida, United States, 32132
        • Research Site
      • Lauderdale Lakes, Florida, United States, 33319
        • Research Site
      • Miami, Florida, United States, 33143
        • Research Site
      • Pinellas Park, Florida, United States, 33781
        • Research Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Research Site
      • Woodstock, Georgia, United States, 30189
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Research Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Research Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Research Site
      • Prairie Village, Kansas, United States, 66208
        • Research Site
      • Wichita, Kansas, United States, 67205
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Research Site
    • Louisiana
      • Jefferson, Louisiana, United States, 70121
        • Research Site
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Research Site
    • Michigan
      • Troy, Michigan, United States, 48085
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Research Site
      • Saint Louis, Missouri, United States, 63141
        • Research Site
      • Saint Peters, Missouri, United States, 63303
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Research Site
    • New York
      • Rochester, New York, United States, 14609
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Research Site
      • Charlotte, North Carolina, United States, 28210
        • Research Site
      • High Point, North Carolina, United States, 27262
        • Research Site
      • Salisbury, North Carolina, United States, 28144
        • Research Site
      • Wilmington, North Carolina, United States, 28401
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Research Site
      • Cincinnati, Ohio, United States, 45224
        • Research Site
      • Cleveland, Ohio, United States, 44122
        • Research Site
      • Columbus, Ohio, United States, 43213
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19152
        • Research Site
      • State College, Pennsylvania, United States, 16801
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Research Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Research Site
    • Texas
      • Austin, Texas, United States, 78745
        • Research Site
      • Bedford, Texas, United States, 76021
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • Houston, Texas, United States, 77055
        • Research Site
      • San Angelo, Texas, United States, 76904
        • Research Site
    • Virginia
      • Arlington, Virginia, United States, 22207
        • Research Site
      • Charlottesville, Virginia, United States, 22911
        • Research Site
      • Danville, Virginia, United States, 24541
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ambulatory
  • Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at screening (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)
  • Pain compatible with OA of the knee(s) for at least 26 weeks prior to screening
  • Primary source of pain throughout the body is due to OA in the target knee
  • Willingness to use an electronic diary on a daily basis in the evening for the screening period and 24-week study duration
  • Negative drug test for opioids and drugs of abuse, except alcohol and marijuana, at screening
  • Subjects with depression or anxiety must be clinically stable for 12 weeks prior to screening, and, if on treatment for depression or anxiety, be on 12 weeks of stable therapy
  • Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
  • Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed

Exclusion Criteria:

  • Women who are pregnant, lactating, or have a positive pregnancy result at screening
  • Women of child bearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period
  • Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized or whom are not using a highly effective method of birth control
  • Body mass index (BMI) > 35
  • Partial or complete joint replacement in either knee
  • Currently requires regular use of ambulatory assistive devices (e.g., wheelchair, parallel bars, walker, canes, or crutches) or use of a lower extremity prosthesis, and/or a structural knee brace
  • Previous participation in a Samumed clinical trial investigating SM04690
  • Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to screening
  • Any planned surgery during the study period
  • History of malignancy within the last 5 years; however, subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible if completely excised. Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years prior to any study injection
  • Comorbid conditions that could affect study endpoint assessments of the target knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout or pseudogout, and fibromyalgia
  • Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, schizoaffective disorder, major depressive disorder, or generalized anxiety disorder
  • Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure, or an observational research trial related to osteoarthritis within 8 weeks prior to any study injection, or planned participation in any such trial
  • Treatment of the target knee with intra-articular glucocorticoids (e.g., methylprednisolone) within 12 weeks prior to screening
  • Any intra-articular injection into the target knee with a therapeutic aim including, but not limited to, viscosupplementation (e.g., hyaluronic acid), platelet-rich plasma (PRP), and stem cell therapies within 24 weeks prior to screening; treatment of the target knee with intra-articular glucocorticoids greater than 12 weeks prior to screening is allowed
  • Treatment with systemic glucocorticoids greater than 10 mg prednisone or the equivalent per day within 4 weeks prior to screening
  • Effusion of the target knee clinically requiring aspiration within 12 weeks prior to screening
  • Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to screening
  • Any known active infections, including urinary tract infection, upper respiratory tract infection, sinusitis, suspicion of intra-articular infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV) at study start
  • Use of centrally acting analgesics (e.g., duloxetine) within 12 weeks prior to screening
  • Use of anticonvulsants within 12 weeks prior to screening, unless used for seizure or migraine prophylaxis
  • Subjects requiring the usage of opioids >1x per week within 12 weeks prior to screening
  • Use of topical local anesthetic agents (gels, creams, or patches such as the Lidoderm patch) for the treatment of knee OA within 7 days of screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 0.07 mg SM04690
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
Drug: SM04690
Healthcare professional-administered intra-articular injection performed once on Day 1 of the study
Experimental: 0.03 mg SM04690
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
Drug: SM04690
Healthcare professional-administered intra-articular injection performed once on Day 1 of the study
Experimental: 0.15 mg SM04690
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
Drug: SM04690
Healthcare professional-administered intra-articular injection performed once on Day 1 of the study
Experimental: 0.23 mg SM04690
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
Drug: SM04690
Healthcare professional-administered intra-articular injection performed once on Day 1 of the study
Placebo Comparator: Placebo
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
Other: Placebo
Healthcare professional-administered intra-articular injection performed once on Day 1 of the study
Sham Comparator: Sham
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
Other: Sham
Healthcare professional-administered intra-articular injection performed once on Day 1 of the study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline Osteoarthritis (OA) Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS)
Time Frame: Baseline and Week 24
Change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 24. The pain NRS is an 11-point scale [0-10] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain (pain as bad as one can imagine).
Baseline and Week 24
Change From Baseline OA Pain in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain)
Time Frame: Baseline and Week 24
Change from baseline OA pain in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 24. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is standardized and reported ranging from 0 to 100 [0 = no pain; 100 = pain as bad as it can be].
Baseline and Week 24
Change From Baseline OA Function in the Target Knee as Assessed by WOMAC Physical Function Subscore (WOMAC Function)
Time Frame: Baseline and Week 24
Change from baseline OA function in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 24. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is standardized and reported ranging from 0 to 100 [0 = no functional disability, 100 = unable to function].
Baseline and Week 24
Change From Baseline in Medial Joint Space Width (mJSW) of the Target Knee
Time Frame: Baseline and Week 24
Change from baseline in mJSW as documented by radiograph of the target knee.
Baseline and Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment (PtGA)
Time Frame: Baseline and Week 24
Change from baseline OA disease activity as assessed by PtGA at Week 24. The PtGA was completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.
Baseline and Week 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline OA Pain in the Target Knee as Assessed by WOMAC Pain Subscore (WOMAC Pain)
Time Frame: Baseline and Week 12
Change from baseline OA pain in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 12. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is standardized and reported ranging from 0 to 100 [0 = no pain, 100 = pain as bad as it can be].
Baseline and Week 12
Change From Baseline OA Function in the Target Knee as Assessed by WOMAC Physical Function Subscore (WOMAC Function)
Time Frame: Baseline and Week 12
Change from baseline OA function in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 12. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is standardized and reported ranging from 0 to 100 [0 = no functional disability, 100 = unable to function].
Baseline and Week 12
Change From Baseline OA Pain in the Target Knee as Assesses by the Weekly Average of Daily Pain NRS
Time Frame: Baseline and Week 12
Change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 12. The pain NRS is an 11-point scale [0-10] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain (pain as bad as one can imagine).
Baseline and Week 12
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment (PtGA)
Time Frame: Baseline and Week 12
Change from baseline OA disease activity as assessed by PtGA at Week 12. The PtGA completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosplice Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SM04690-OA-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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