OsteoarthritisPhase 2NCT02558439
Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain
A Phase 2 study testing CNTX-4975 in people with Osteoarthritis, run by Centrexion Therapeutics at 22 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a single injection of CNTX-4975 in subjects with chronic, moderate to severe osteoarthritis knee pain. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- CNTX-4975
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 22 sitesUnited States
- Study dates
- Aug 2015to Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiography of both knees with a posterior-anterior, fixed flexion view taken during the Screening period. The index knee must show evidence of chronic OA.
- Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 2 months prior to Screening, as assessed by the Investigator.
- A specified mean pain score in the index knee over the 7 days prior to dosing, based on question A1 of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC A1).
- Specified baseline and screening scores on the WOMAC A1
- Body Mass Index ≤ 45 kg/m2.
- Subjects must have had a therapeutic failure (no relief, or inadequate relief), and/or AEs resulting in stopping treatment, and/or contraindication to the standard of care appropriate to the severity of the index knee OA pain they are experiencing.
Who cannot join
- Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 12 months.
- Prior arthroscopic surgery of the index knee within 3 months of Screening.
- Any painful conditions of the index knee due to joint disease other than OA.
- Mild pain in the non-index knee when walking.
- Other chronic pain anywhere in the body that requires the use of analgesic medications.
- Secondary OA of the index knee due to acute traumatic injury.
Show all 15Show fewer
- Significant current or past instability (e.g., cruciate ligament tear or rupture or previous repair) or misalignment (> 10 degrees varus or valgus) of the index knee
- Has used topical capsaicin on the index knee within 90 days of Screening.
- Corticosteroid injection in the index knee within 90 days of Screening.
- Received IA viscosupplementation (e.g., Synvisc®, Hyalgan®) within 90 days of Screening.
- Prior participation in an ALGRX 4975 or CNTX-4975 study.
- Has any of the following characteristics:
- active or historic substance use disorder within the previous year as defined by the Diagnostic and Statistical Manual for Mental Health Disorders, fifth edition, or
- tests positive upon urine drug screen for a substance of abuse.
- Has moderate to severe depression or anxiety.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University Orthopedics Center
Altoona, Pennsylvania, 16602
Dream Team Clinical Research, LLC
Anaheim, California, 92801
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216
Hope Clinical Research, LLC
Canoga Park, California, 91303
Avail Clinical Research, LLC
DeLand, Florida, 32720
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
TriWest Research Associates
El Cajon, California, 92020
Drug Trials America
Hartsdale, New York, 10530
Finlay Research Clinic
Hialeah, Florida, 33012
Eastern Research
Hialeah, Florida, 33013
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
BioSolutions Clinical Research Center
La Mesa, California, 91941
Sunrise Medical Research
Lauderdale Lakes, Florida, 33319
Axis Clinical Trials
Los Angeles, California, 90036
M&M Medical Center, Inc
Miami, Florida, 85704
Manhattan Medical Research Practice
New York, New York, 10016
Compass Research, LLC
Orlando, Florida, 32806
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
University Orthopedics Center
State College, Pennsylvania, 16801
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Compass Research, LLC
The Villages, Florida, 32162
Advanced Arizona Clinical Research
Tucson, Arizona, 85704
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging 24-Week Study to Evaluate the Safety and Efficacy of a Single Injection of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain
The purpose of this study is to evaluate the safety and efficacy of a single injection of CNTX-4975 in subjects with chronic, moderate to severe osteoarthritis knee pain.
- Conditions
- Osteoarthritis
- Being tested
- CNTX-4975, Placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTX-4975Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will receive a single injection of placebo into the index knee following local anesthesia and adjunct joint cooling. Receives: Other: Placebo |
| 0.5 mg CNTX-4975 | Experimental | Subjects will receive a single injection of 0.5 mg CNTX-4975 into the index knee following local anesthesia and adjunct joint cooling. Receives: Drug: CNTX-4975 |
| 1.0 mg CNTX-4975 | Experimental | Subjects will receive a single injection of 1.0 mg CNTX-4975 into the index knee following local anesthesia and adjunct joint cooling. Receives: Drug: CNTX-4975 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline through Week 12 in average knee index pain with walking over previous 24 hours using WOMAC A1 question in subjects treated with CNTX-4975 1.0 mg compared to placebo in subjects with osteoarthritis (OA) of the knee
Measured: At 12 Weeks
Secondary outcomes (3)
Change from Baseline through Week 12 in average index knee pain with walking using WOMAC A1 question in subjects treated with CNTX 0.5 mg compared to placebo
Measured: At 12 Weeks
Change from Baseline to each study visit through Week 24 in average index knee pain with walking using WOMAC A1 in subjects treated with CNTX-4975 compared to placebo
Measured: Up to 24 weeks
Change from Baseline through Week 4 in the average index knee pain with walking using the WOMAC A1 question
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centrexion Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558439
- Sponsor's protocol ID
- 4975-OA-502
- Status last verified
- Jul 2017
- First submitted
- 20 Sep 2015
- Last updated
- 8 Aug 2017
- Results posted
- No
Publications
Stevens RM, Ervin J, Nezzer J, Nieves Y, Guedes K, Burges R, Hanson PD, Campbell JN. Randomized, Double-Blind, Placebo-Controlled Trial of Intraarticular Trans-Capsaicin for Pain Associated With Osteoarthritis of the Knee. Arthritis Rheumatol. 2019 Sep;71(9):1524-1533. doi: 10.1002/art.40894. Epub 2019 Jul 17.
PubMed 30888737
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging 24-Week Study to Evaluate the Safety and Efficacy of a Single Injection of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain
- ClinicalTrials.gov ID
- NCT02558439
- Acronym / sponsor ID
- 4975-OA-502
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of a single injection of CNTX-4975 in subjects with chronic, moderate to severe osteoarthritis knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboSubjects will receive a single injection of placebo into the index knee following local anesthesia and adjunct joint cooling. |
| 0.5 mg CNTX-4975 | Experimental | Drug: CNTX-4975Subjects will receive a single injection of 0.5 mg CNTX-4975 into the index knee following local anesthesia and adjunct joint cooling. |
| 1.0 mg CNTX-4975 | Experimental | Drug: CNTX-4975Subjects will receive a single injection of 1.0 mg CNTX-4975 into the index knee following local anesthesia and adjunct joint cooling. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Radiography of both knees with a posterior-anterior, fixed flexion view taken during the Screening period. The index knee must show evidence of chronic OA.
- Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 2 months prior to Screening, as assessed by the Investigator.
- A specified mean pain score in the index knee over the 7 days prior to dosing, based on question A1 of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC A1).
- Specified baseline and screening scores on the WOMAC A1
- Body Mass Index ≤ 45 kg/m2.
Key exclusion criteria (15 listed)
- Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 12 months.
- Prior arthroscopic surgery of the index knee within 3 months of Screening.
- Any painful conditions of the index knee due to joint disease other than OA.
- Mild pain in the non-index knee when walking.
- Other chronic pain anywhere in the body that requires the use of analgesic medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNTX-4975 | Drug | 0.5 mg CNTX-4975, 1.0 mg CNTX-4975 |
| Placebo | Other | Placebo |
Primary outcome
Change from Baseline through Week 12 in average knee index pain with walking over previous 24 hours using WOMAC A1 question in subjects treated with CNTX-4975 1.0 mg compared to placebo in subjects with osteoarthritis (OA) of the knee
Time frame: At 12 Weeks
3 secondary outcomes
Change from Baseline through Week 12 in average index knee pain with walking using WOMAC A1 question in subjects treated with CNTX 0.5 mg compared to placebo
Time frame: At 12 Weeks
Change from Baseline to each study visit through Week 24 in average index knee pain with walking using WOMAC A1 in subjects treated with CNTX-4975 compared to placebo
Time frame: Up to 24 weeks
Change from Baseline through Week 4 in the average index knee pain with walking using the WOMAC A1 question
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Derived from this study: PubMed 30888737Stevens RM, Ervin J, Nezzer J, Nieves Y, Guedes K, Burges R, Hanson PD, Campbell JN. Randomized, Double-Blind, Placebo-Controlled Trial of Intraarticular Trans-Capsaicin for Pain Associated With Osteoarthritis of the Knee. Arthritis Rheumatol. 2019 Sep;71(9):1524-1533. doi: 10.1002/art.40894. Epub 2019 Jul 17.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CNTX-4975 in people with Osteoarthritis, run by Centrexion Therapeutics at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline through Week 12 in average knee index pain with walking over previous 24 hours using WOMAC A1 question in subjects treated with CNTX-4975 1.0 mg compared to placebo in subjects with osteoarthritis (OA) of the knee (time frame: At 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02558439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.