The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee

December 14, 2018 updated by: Centrexion Therapeutics

A Phase 1b Study to Characterize the Effect of Injection Site Cooling on Pain Experienced After CNTX-4975-05 (Trans-capsaicin) Intra-articular and Capsaicin Intradermal Injections in Healthy Volunteers and Subjects With Bilateral Painful Knee Osteoarthritis

A clinical study to measure the effects of injection-site cooling on pain experienced after knee injections of capsaicin in healthy subjects and in patients with knee osteoarthritis.

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.
20

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 1

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

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Cohort 1 Key Inclusion Criteria:

  • Subject is aged between 18 and 45 years, inclusive.
  • Subjects Body Mass Index (BMI) is between 18 and 32 kg/m^2, inclusive and subject's weight is greater than or equal to 50 kg.
  • Subjects must be in good health, in the opinion of the Investigator, as determined by a medical history, physical examination, clinical laboratory tests, vital signs and 12 lead electrocardiogram (ECG).

Cohort 1 Key Exclusion Criteria:

  • Subject has had a clinically significant illness that has not completely resolved in the four weeks before screening.
  • Subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial.

Cohorts 2-4 Key Inclusion Criteria:

  • Subject is aged between 45 and 75 years, inclusive.
  • Subject's BMI is between 18 and 32 kg/m^2, inclusive and subject's weight is greater than or equal to 50 kg.
  • Subject has a diagnosis of bilateral moderate to severe painful knee OA (subjects will be required to have a score on Pain with walking in the previous 24 hours, of 4 to 9, inclusive NPRS 0-10). The condition must be chronic with a history of painful arthritis for at least 3 months prior to entry in the study.

Cohorts 2-4 Key Exclusion Criteria:

  • Subject has had a clinically significant illness, other than osteoarthritis, that has not completely resolved in the four weeks before screening.
  • Subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial.
  • Subject has used analgesic medications in the 2 days prior to dosing, except for paracetamol, as needed.
  • Subject has used topical medications applied to the knee for OA pain (including capsaicin, lidocaine, prescription or OTC medications) from 90 days prior to screening through to dosing.
  • Subject has been injected with corticosteroids in the knee 90 days prior to screening through to dosing.
  • Subject currently uses opioids for any condition other than OA knee pain (maximum dose 15 mg hydrocodone, or equivalent, per day prescribed by a physician).

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

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: Cohort 1
A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).
Other: Ice Pack and Cooling Device
A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).
Drug: Capsaicin
Four intradermal injections of capsaicin, two on each forearm.
EXPERIMENTAL: Cohort 2
Controlled cooling wrap versus ice pack cooling.
Drug: Capsaicin
Four intradermal injections of capsaicin, two on each forearm.
Drug: CNTX-4975-05 (trans-capsaicin)
Controlled cooling wrap vs ice pack cooling after single IA injection of 1 mg CNTX-4975-05 in each arm after single IA (15 mL) injection of 2% lidocaine (without epinephrine).
Drug: CNTX-4975-05 (trans-capsaicin)
Controlled cooling parameters will be determined after evaluation of data from prior Cohort(s) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.
Drug: CNTX-4975-05 (trans-capsaicin)
Controlled cooling with knee device vs no cooling (determined after evaluation of data from previous cohorts) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.
EXPERIMENTAL: Cohort 3
Controlled cooling parameters will be determined after evaluation of data from prior cohorts.
Drug: Capsaicin
Four intradermal injections of capsaicin, two on each forearm.
Drug: CNTX-4975-05 (trans-capsaicin)
Controlled cooling wrap vs ice pack cooling after single IA injection of 1 mg CNTX-4975-05 in each arm after single IA (15 mL) injection of 2% lidocaine (without epinephrine).
Drug: CNTX-4975-05 (trans-capsaicin)
Controlled cooling parameters will be determined after evaluation of data from prior Cohort(s) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.
Drug: CNTX-4975-05 (trans-capsaicin)
Controlled cooling with knee device vs no cooling (determined after evaluation of data from previous cohorts) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.
EXPERIMENTAL: Cohort 4
Controlled cooling with knee device versus no cooling (determined after evaluation of data from previous cohorts).
Drug: Capsaicin
Four intradermal injections of capsaicin, two on each forearm.
Drug: CNTX-4975-05 (trans-capsaicin)
Controlled cooling wrap vs ice pack cooling after single IA injection of 1 mg CNTX-4975-05 in each arm after single IA (15 mL) injection of 2% lidocaine (without epinephrine).
Drug: CNTX-4975-05 (trans-capsaicin)
Controlled cooling parameters will be determined after evaluation of data from prior Cohort(s) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.
Drug: CNTX-4975-05 (trans-capsaicin)
Controlled cooling with knee device vs no cooling (determined after evaluation of data from previous cohorts) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.

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
Numerical Pain Rating Scale (NPRS): Injection-site Pain
Time Frame: Days 1 and 7
Cohorts 2-4: Change in injection-site pain following intra-articular (IA) administration of CNTX-4975-05 (trans-capsaicin) scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Days 1 and 7

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
IA Temperature
Time Frame: Days 1 and 7
Cohorts 1-4: IA temperature measurements.
Days 1 and 7
Numerical Pain Rating Scale (NPRS): Procedural Pain
Time Frame: Days 1 and 7
Cohort 1: Procedural pain following single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine) using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Days 1 and 7
Numerical Pain Rating Scale (NPRS): Procedural Pain
Time Frame: Days 1 and 7
Cohorts 2-4: Procedural pain following intradermal (ID) administration of the challenge agent capsaicin as a function of temperature scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Days 1 and 7
Numerical Pain Rating Scale (NPRS): Pain with Walking
Time Frame: Screening through Day 42
Cohorts 2-4: Average pain with walking over the past 24 hours scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Screening through Day 42
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Screening through Day 42
Cohorts 2-4: Calculation of KOOS for each painful osteoarthritis knee on a scale of 0 to 100 with 0 representing extreme problems and 100 representing no problems.
Screening through Day 42
Patient Global Impression of Change (PGIC)
Time Frame: Screening through Day 42
Cohorts 2-4: Change in knee pain for each painful osteoarthritis knee scored using PGIC on a scale of 1 to 7 with 1 representing very much improved and 7 representing very much worse.
Screening through Day 42
Numerical Pain Rating Scale (NPRS): Thermal Pain
Time Frame: Between Days 28 and 35 inclusive; and Day 42
Cohorts 1-4: Thermal pain approximately two weeks following intradermal (ID) administration of the challenge agent capsaicin scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Between Days 28 and 35 inclusive; and Day 42

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.
Centrexion Therapeutics

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.
March 21, 2018

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.
July 27, 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.
August 3, 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).
March 4, 2018

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.
March 14, 2018

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.
March 21, 2018

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.
December 19, 2018

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.
December 14, 2018

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.
December 1, 2018

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.
  • CNTX-4975i-OA-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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