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

NCT03472677 | Completed Phase 1 FDA Drug

• 1 other identifier: CNTX-4975i-OA-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Knee Pain

Outcome Measures

Primary Outcomes (1)

• Numerical Pain Rating Scale (NPRS): Injection-site Pain

  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 Outcomes (7)

• IA Temperature

  Days 1 and 7

• Numerical Pain Rating Scale (NPRS): Procedural Pain

  Days 1 and 7

• Numerical Pain Rating Scale (NPRS): Procedural Pain

  Days 1 and 7

• Numerical Pain Rating Scale (NPRS): Pain with Walking

  Screening through Day 42

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Screening through Day 42

Study Arms (4)

Cohort 1

EXPERIMENTAL

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; Drug: Capsaicin

Cohort 2

EXPERIMENTAL

Controlled cooling wrap versus ice pack cooling.

Drug: CNTX-4975-05 (trans-capsaicin); Drug: Capsaicin

Cohort 3

EXPERIMENTAL

Controlled cooling parameters will be determined after evaluation of data from prior cohorts.

Drug: CNTX-4975-05 (trans-capsaicin); Drug: Capsaicin

Cohort 4

EXPERIMENTAL

Controlled cooling with knee device versus no cooling (determined after evaluation of data from previous cohorts).

Drug: CNTX-4975-05 (trans-capsaicin); Drug: Capsaicin

Interventions

Ice Pack and Cooling Device OTHER

A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).

Cohort 1

CNTX-4975-05 (trans-capsaicin) DRUG

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).

Cohort 2

Capsaicin DRUG

Four intradermal injections of capsaicin, two on each forearm.

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.
• 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).

Sponsors & Collaborators

• Centrexion Therapeutics: lead

Study Sites (1)

MAC Clinical Research

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Randall M. Stevens, MD

  Centrexion Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 21, 2018
• Study Start: March 21, 2018
• Primary Completion: July 27, 2018
• Study Completion: August 3, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

GB (1)