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A Phase 2 Clinical Trial to Examine the Comparative Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5, and CGS-200-0

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ClinicalTrials.gov Identifier: NCT03528369
Recruitment Status : Active, not recruiting
First Posted : May 17, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Vizuri Health Sciences LLC

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.

Subjects will be randomized to one of the three Arms in this study: CGS-200-1 or CGS-200-5 or CGS-200 Vehicle (CGS-200-0). All subjects will receive 4 consecutive days of treatment and will then be followed up until the Day 94 visit.

Even though both knee(s) will receive application of study test materials, with regard to reduction in WOMAC pain and VAS pain score associated with study treatments, only one knee will be indicated as the "Study Knee". This will be the knee with the highest WOMAC pain score at screening. If both knees have equal WOMAC pain scores at baseline, then the right knee will be considered the "Study Knee" with regard to WOMAC pain and VAS pain score reduction.

Data will be collected from Day 1 through Day 5 and then again on Days 19, 35, 64 and 94 for efficacy, tolerability, and safety measures. The Investigators, all site staff and Clinical Research Organization (CRO) personnel (except the Medical Monitor providing safety oversight) directly involved in the study will remain blinded to the treatment assignment throughout the trial.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Pain Drug: CGS-200-1 Drug: CGS-200-5 Drug: CGS-200 Vehicle Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Double-Blind Clinical Trial to Examine the Comparative Effects on Osteoarthritic Knee Pain of CGS-200-1 (1% Capsaicin Topical Liquid), CGS-200-5 (5% Capsaicin Topical Liquid), and CGS-200-0 (Vehicle, No Capsaicin)
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : October 14, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: CGS-200-1
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-200-1 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.

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

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




Primary Outcome Measures :
  1. Primary Efficacy Endpoint: Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from Baseline to Day 35 [ Time Frame: 35 days ]
    The Primary Efficacy endpoint of this study will be to examine the extent of reduction in the 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).

  2. Primary Safety Endpoint #1: Frequency and severity of skin reaction Adverse Events (erythema, scaling, pruritus, or other) of clinical concern. [ Time Frame: 35 days ]
    The application of the study drug does not produce skin reactions (erythema, scaling, pruritus, or other) to a degree that is clinically of concern. Scoring of erythema and scaling at the application sites and of pruritus will be assessed per specified scoring systems.

  3. Primary Safety Endpoint #2: Frequency of Serious Adverse Events (SAEs) related to the study treatment [ Time Frame: 35 days ]
    No SAE's either possibly, probably or definitely associated with study treatments.

  4. Primary Safety Endpoint #3(a): The proportion of subjects with other than minimal - mild (Grade 1 or Grade 2) hematologic toxicities does not change significantly from baseline. [ Time Frame: 35 days ]
    Change, for any cell type or hematology parameter, from within normal limits to above or below normal limits. Grade per Rheumatology Common Toxicity Criteria v2.0. (RCTC) is amount of change. If high or low at screening, then change such that toxicity grade increases from level at screening. Comparison is between the CGS-200-5 group to the CGS-200-0 group or comparing the CGS-200-1 group to the CGS-200-0 group.

  5. Primary Safety Endpoint #3(b): The proportion of subjects with other than minimal - mild (Grade 1 or Grade 2) serum chemistry toxicities is not significantly different from baseline. [ Time Frame: 35 days ]
    Change, for any analyte, from within normal limits to above or below normal limits. Grade per RCTC is amount of change. If high or low at screening, then change such that toxicity grade increases from level at screening. Comparison is between the CGS-200-5 group to the CGS-200-0 group or comparing the CGS-200-1 group to the CGS-200-0 group.

  6. Primary Safety Endpoint #3(c): The proportion of subjects with other than minimal - mild (Grade 1 or Grade 2) urinalysis toxicities is not significantly different from baseline. [ Time Frame: 35 days ]
    Change, for any analyte, from within normal limits to above or below normal limits. Grade per RCTC is amount of change. If high or low at screening, then change such that toxicity grade increases from level at screening. Comparison is between the CGS-200-5 group to the CGS-200-0 group or comparing the CGS-200-1 group to the CGS-200-0 group.


Secondary Outcome Measures :
  1. Secondary Efficacy Endpoint #1: Extent of reduction in WOMAC pain score from Baseline to Day 5, Day 19, Day 64, and Day 94 [ Time Frame: 5 days, 19 days, 64 days, and 94 days ]
    The extent of reduction in the WOMAC pain score, relative to baseline, provided by once daily, one-hour application of CGS-200-0, CGS-200-1 and CGS-200-5 from Baseline to Day 5, Baseline to Day 19, Baseline to Day 64, and Baseline to Day 94.

  2. Secondary Efficacy Endpoint #2: WOMAC total, stiffness, and function scores from Baseline to Day 5, Day 19, Day 64, and Day 94 [ Time Frame: 5 days, 19 days, 64 days, and 94 days ]
    Day 5, 19, 35, 64 and 94 WOMAC scores on the stiffness and function subscales as well as total WOMAC score (including the WOMAC pain score).

  3. Secondary Safety Endpoint #1: Frequency of specific Adverse Events (AEs) by study arm [ Time Frame: 94 days ]
    The distribution by study arms of specific AEs (i.e.: local application site reactions, and other AEs (inclusive of findings for hematology, serum chemistry and urinalysis).

  4. Secondary Safety Endpoint #2: Usage of concomitant pain medications [ Time Frame: 94 days ]
    Evaluate the amount of concomitant pain medications used overtime

  5. Secondary Tolerability Endpoint #1: Patient reported burning-stinging pain (BSP) during application of the study drug. [ Time Frame: 60 minutes ]
    The application of study drug does not produce BSP at the application site to a degree that is not acceptable to the subject. BSP at the application site will be assessed using a 0 - 10 numerical rating scale (NRS) without guideposts. "Acceptability" of BSP will be queried per subject at the end of each application period.

  6. Secondary Tolerability Endpoint #2: Severity of pruritus during study drug application and up to 24 hours after application, as measured by numerical scale provided in Appendix F of the protocol. [ Time Frame: 1 day ]
    The application of the study drug does not produce pruritus during application or in the 24 hrs post-application to a degree that is not acceptable to the subject or, if bothersome to the subject, cannot be managed by application of ice or a cold pack or compress.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528369


Locations
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
Clinical Research of West Florida, Inc.
Tampa, Florida, United States, 33603
McIlwain Medical Group
Tampa, Florida, United States, 33613
United States, Ohio
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45212
United States, Texas
Radiant Research, Inc.
Dallas, Texas, United States, 75234
Radiant Research, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Vizuri Health Sciences LLC

Responsible Party: Vizuri Health Sciences LLC
ClinicalTrials.gov Identifier: NCT03528369     History of Changes
Other Study ID Numbers: VZU00025
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs