A Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5 and Vehicle Control

NCT03528369 | Completed Phase 2 Results FDA Drug

• 1 other identifier: VZU00025
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 6

Brief Summary

This is a multi-center, randomized, double-blind clinical trial to examine the comparative effects on OAKP of CGS-200-1 (1% Capsaicin content) (N=40), CGS-200-5 (5% Capsaicin content) (N=40), and CGS-200 Vehicle (no Capsaicin) (N=40) in subjects with OA of the knees according to the 1986 American College of Rheumatology (ACR) criteria. Assigned doses will be applied at the clinic for 60 minutes on each of four consecutive days.

Conditions

Osteoarthritis, Knee; Pain

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Endpoint: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 35

  The Primary Efficacy endpoint of this study will be to examine the extent of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, relative to baseline, provided by once daily, one-hour application of Vehicle (CGS-200-0), CGS-200-1 and CGS-200-5 at Baseline (\< 30 minutes prior to first daily application) and Day 35 (31 days after fourth daily application). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score is 5 questions relating to pain that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 500. Reduction in pain is expressed as a difference from baseline to Study Day 35. Positive numbers indicate increases and negative numbers indicate decreases. .

  35 days after the last dose of study drug on Day 4

Secondary Outcomes (4)

• Secondary Efficacy Endpoint #1: Extent of Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 5, 19, 64 and 94.

  Days 5, 19, 65 and 94 after the last dose of study drug on Day 4

• Patient Reported Burning-Stinging Pain (BSP) During Application of Study Drug.

  60 minutes after study drug application on Study Days 1,2,3,4

• Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores.

  Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4

• Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores.

  Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4

Other Outcomes (2)

• Number of Subjects With Skin Reactions of Erythema or Pruritus.

  Study Day 1 through Study Day 35 after the first application of study drug (Study Day 1)

• Number of Subjects With Durability of Efficacy Response

  Days 35, 64 and 94 day after the last dose of study drug on Study Day 4

Study Arms (3)

CGS-200-1

EXPERIMENTAL

CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.

Drug: CGS-200-1

CGS-200-5

EXPERIMENTAL

CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.

Drug: CGS-200-5

CGS-200 Vehicle

SHAM COMPARATOR

CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.

Drug: CGS-200 Vehicle

Interventions

CGS-200-1 DRUG

CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.

Also known as: CGS-200 (1% capsaicin)

CGS-200-1

CGS-200-5 DRUG

CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.

Also known as: CGS-200 (5% capsaicin)

CGS-200-5

CGS-200 Vehicle DRUG

CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.

Also known as: CGS-200 (0% capsaicin)

CGS-200 Vehicle

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritis (OA) of both knees;
• OA of both knees must be confirmed by tibiofemoral joint radiographs obtained within the past 6 months;
• Rheumatoid factor (RF) negative and Erythrocyte sedimentation rate (ESR) \<40 mm/hr;
• Chronic knee pain in at least 1 knee for \> 3 months;
• WOMAC pain score of \> 250 (using VAS WOMAC format) at screening, and at baseline, in at least one knee;
• Knee pain score of \> 5 on the NRS pain scale at screening, and at baseline, in at least one knee;
• Knee pain is not potentially due to acute trauma unrelated to OA (no acute traumatic knee injury in medical history);
• No burning-stinging pain, unrelated to subject's knee pain, at intended site of application;
• Knee pain must be greater than pain in any other part of subject's body;
• American College of Rheumatology (ACR) global functional status I, II, or III (excluding IV).

You may not qualify if:

• Spontaneously improving or rapidly deteriorating OA of the knee;
• Rheumatoid or psoriatic arthritis, or a form of arthritis (e.g. gout, pseudogout), Paget's disease of bone, or any other disease affecting the joints that are inconsistent with a diagnosis of idiopathic OA;
• Labile or poorly controlled hypertension;
• Use of steroids for 1 month prior to screening, or intraarticular-visco-supplementation within 3 months prior to screening;
• Used any capsaicin-containing product on or in the vicinity of the knee within 4 weeks prior to screening;
• Used topically applied products (including emollients or moisturizers) on or in the vicinity of the knees or shaved the knees within 2 days prior to the first application of study drug; or an open wound near the knee; cutaneous erythema or edema; any inflammatory skin lesions such as eczema or psoriasis; cutaneous infections; or any other compromise of the skin;
• Requires or anticipates any surgical procedure within 3 months prior to screening, has had surgery on the affected joint within 6 months prior to screening, has a prosthesis in either knee, or would require surgery while participating in the trial.

Sponsors & Collaborators

• Propella Therapeutics: lead

Study Sites (6)

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33603, United States

Location

McIlwain Medical Group

Tampa, Florida, 33613, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Radiant Research, Inc.

Dallas, Texas, 75234, United States

Location

Radiant Research, Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Results Point of Contact

• Title: Vice President Clinical Operations
• Organization: Vizuri Health Sciences

twarneke@vizuriusa.com

919-397-4782

Study Officials

• Vice President Clinical Operations

  Vizuri Health Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: May 17, 2018
• Study Start: May 14, 2018
• Primary Completion: October 14, 2018
• Study Completion: December 30, 2018
• Last Updated: October 30, 2024
• Results First Posted: December 17, 2019

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)