A Randomized, Multi-Dose, Placebo-Controlled Pain Relief Study of 0.25% 920-CGS-200 in Subjects With Preexisting Knee Pain (for at Least 6 Months) Caused by Osteoarthritis (OA)

Randomized, Multi-Dose, Placebo-Controlled OA Knee Pain Relief Study of 0.25% 920-CGS-200



Sponsors

Lead Sponsor


Collaborators



Source

Vizuri Health Sciences LLC

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No

Is Us Export

No


Brief Summary

This is a study of a OTC TFM compliant, capsaicin-based (0.25%) topical analgesic for
management of osteoarthritis (OA) knee pain (OAKP). Subjects meeting the inclusion criteria
and not meeting the exclusion criteria will be randomized into one of four groups: once
daily treatment with active product, once daily treatment with product vehicle (no
capsaicin), twice daily treatment with active product, and twice daily treatment with
product vehicle (no capsaicin), all for 7 consecutive days of treatment. The twice daily
treatments are spaced approximately 12 hrs apart. OAKP is assessed by the 100 mm VAS scale.
OAKP assessments are done each day for 28 days. Tolerability data are also collected.

Detailed Description

This is a study of a OTC TFM compliant, capsaicin-based (0.25%) topical analgesic for
management of osteoarthritis (OA) knee pain (OAKP). Subjects meeting the inclusion criteria
and not meeting the exclusion criteria will be randomized into one of four groups: once
daily treatment with active product, once daily treatment with product vehicle (no
capsaicin), twice daily treatment with active product, and twice daily treatment with
product vehicle (no capsaicin), all for 7 consecutive days of treatment. The twice daily
treatments are spaced approximately 12 hrs apart. Both knees received study drug treatment
but only one knee per subject was assigned as the "study knee".

OAKP is assessed by the 100 mm VAS scale and the response criterion is a 50% or greater
reduction in OAKP from baseline. Baseline is defined as the VAS recorded not more than 30
minutes before the first study drug application (on Study Day 1). For subjects in the once
daily (QD) groups the OAKP assessments were at 12 hrs after the initial application (during
Study Day 1) and 24 hrs(Study Day 2) after the initial application and then once in the
morning on Study Days 3 - 28. For subjects in the twice daily (BID) groups the OAKP
assessments were at 12 hrs after the initial application (during Study Day 1) and 24
hrs(Study Day 2) after the initial application and then once in the morning and once 12 hrs
later on Study Days 3 - 28.

Tolerability data are also collected as reported burning-stinging pain, erythema and/or
pruritus at the site of application.

Overall Status

Completed

Start Date

2016-07-01

Completion Date

2016-10-01

Primary Completion Date

2016-10-01

Phase

Phase 4

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Proportion of subjects with 50% or greater pain score reduction
Daily for 7 day course of treatment

Secondary Outcome

Measure

Time Frame

Post-treatment mean success subject proportion
Study Day 8 through Study Day 28

Enrollment

120

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

OTC TFM compliant product with 0.25% capsaicin

Arm Group Label

QD-Active

BID-Active


Other Name

PainBloc24(tm)


Intervention Type

Other

Intervention Name


Description

This is the vehicle for the active treatment drug product

Arm Group Label

QD-Vehicle

BID-Vehicle




Eligibility

Criteria

Inclusion Criteria:

1. Subject has granted written informed consent.

2. Subject is at least 18 years of age.

3. Subject has knee pain with radiographic evidence of OA in at least one knee
(including an x-ray within the previous 2 years).

4. Subject's OAKP has been present for ≥ 6 months.

5. Subject has OAKP of ≥ 50 mm in one knee based on the VAS at screening.

6. Subject has regularly used topical OTC pain relief products or OTC oral medication
(acetaminophen or ibuprofen) to treat/manage pain from OA in the previous 3 months.

7. Subject is in good general health and free of any disease state or physical condition
which, in the PI's opinion, exposes the subject to an unacceptable risk by study
participation.

8. Subject is capable of understanding and complying with all instructions and study
procedures, including the ability to accurately evaluate their symptoms.

9. Subject must be a male or non-pregnant female. If female, subject must be past
childbearing age or otherwise must test negative for pregnancy. Males and females
must agree to use effective birth control during the study or for at least 30 days
after last dose of study investigational product, if unable to complete the study.

Exclusion Criteria:

1. Subject has spontaneously improving or rapidly deteriorating OA or knee pain.

2. Subject has rheumatoid or psoriatic arthritis, or a form of arthritis inconsistent
with a diagnosis of OA.

3. Subject has used any topical steroids on or in the vicinity of the knees within 1
week prior to Screening, or has had a knee injection within 1 month prior to
Screening.

4. Subject is currently taking prescription pain medication.

5. Subject has shaved their knees within 2 days of first day of treatment (Day 1).

6. Subject has used any capsaicin containing product on or in the vicinity of the knees
within 2 weeks prior to first day of treatment (Day 1).

7. Subject has used any topically applied products (including emollient/moisturizer) on
or in the vicinity of the knees within 2 weeks prior to first day of treatment (Day
1).

8. Subject has used topical therapy on the knees that, in the PI's opinion, might affect
the study evaluations of signs and/or symptoms.

9. Subject has broken or damaged skin on their knees, or an open wound near the knees.

10. Subject has a history of allergy/sensitivity to topical substances.

11. Subject is not able to understand the nature, importance, or consequences of the
study.

12. Subject has a psychiatric disorder or has significant anxiety or depression that, in
the PI's opinion, could interfere with the subject's ability to accurately assess
their pain, adhere to study instructions, or complete the study.

13. Subject has hypertension that is not adequately controlled (medication to treat
hypertension is allowed), vascular disease, psychological disorder, or other
condition that, in the PI's opinion, contraindicate the use of medication.

14. Is obese with a Body Mass Index (BMI) of greater than 40 kg/m2.

15. Subject requires a surgical procedure in the immediate future.

16. Subject is pregnant or nursing.

17. Subject has been treated with an investigational drug, device, or therapy within 30
days prior to first day of treatment (Day 1).

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Alan A Ryan, Ph.D.
Study Director
Palm Beach CRO

Verification Date

2017-04-01

Lastchanged Date

2017-04-18

Firstreceived Date

2017-04-18

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

4

Intervention Browse

Mesh Term

Capsaicin


Arm Group

Arm Group Label

QD-Active

Arm Group Type

Active Comparator

Description

40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee


Arm Group Label

QD-Vehicle

Arm Group Type

Placebo Comparator

Description

20 subjects receiving once daily application of drug product vehicle (i.e.. with no capsaicin) to the knee


Arm Group Label

BID-Active

Arm Group Type

Active Comparator

Description

40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee


Arm Group Label

BID-Vehicle

Arm Group Type

Placebo Comparator

Description

20 subjects receiving twice daily application of drug product vehicle (i.e.. with no capsaicin) to the knee



Firstreceived Results Date

N/A

Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

Active treatment compared to drug vehicle as placebo

Primary Purpose

Supportive Care

Masking

Participant, Care Provider, Investigator

Masking Description

Study medications were number coded only and identical in physical characteristics. Randomization coding was held only at the manufacturing site until data lock.



ClinicalTrials.gov processed this data on April 21, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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