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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • 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

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
Intervention / Treatment
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

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

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

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)

March 21, 2018

Primary Completion (ACTUAL)

July 27, 2018

Study Completion (ACTUAL)

August 3, 2018

Study Registration Dates

First Submitted

March 4, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (ACTUAL)

March 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 14, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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