A Safety and Effectiveness Pilot Study of PRF-108 and PRF-110 in Healthy Volunteers

NCT ID: NCT00883194

Last Updated: 2020-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-04-30

Brief Summary

This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers. PRF-108 and PRF-110 are designed to deliver slow release of ropivacaine over 72 hours.

Detailed Description

This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers. PRF-108 and PRF-110 are designed to deliver slow release of ropivacaine over 72 hours.

The purpose of this study is to investigate the safety (side effects if any occurs) associated with the single administration of PRF-108 or PRF-110 and evaluate their analgesic effect in an experimentally induced pain model compared with ropivacaine Solution 0.5% and Vehicle Gel.

Conditions

Pain

Keywords

Experimental Pain Model

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

PRF-108 Gel, 4% ropivacaine

Group Type: EXPERIMENTAL

PRF-108

Intervention Type: DRUG

Ropivacaine

2

PRF-108 Gel, Vehicle

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

PRF-108 Placebo

3

Ropivacaine Solution 0.5%

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

Solution

PRF-110, 4%

PRF-110, 4% ropivacaine

Group Type: EXPERIMENTAL

PRF-110

Intervention Type: DRUG

Interventions

PRF-108

Ropivacaine

Intervention Type: DRUG

Placebo

PRF-108 Placebo

Intervention Type: DRUG

Ropivacaine

Solution

Intervention Type: DRUG

PRF-110

Intervention Type: DRUG

Other Intervention Names

ropivacaine

Eligibility Criteria

Inclusion Criteria

1. Male subjects between 18-60 years of age;

2. Subjects are within ±10% of ideal body weight/height (based on frame size) as given by the Metropolitan Life Insurance Tables;

3. Subjects are ASA Category I and in normal physical health as judged by physical and laboratory examinations and have a negative urine based screen for drugs of abuse;

4. Subjects must agree to refrain from ingesting any analgesic medication for 3 days or 5 half-lives of the drug prior to and during the study period and alcohol for 1 day prior to and during the study period;

5. Subjects can tolerate a 0.5mL injection of saline in the lower back area.

6. The subject is capable of reading, comprehending, and signing the informed consent form.

Exclusion Criteria

1. Subjects with a history of any significant hepatic, renal, endocrine, cardiac, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders, including glaucoma, diabetes, emphysema, and chronic bronchitis;

2. Subjects with a history of any type of cancer;

3. Subjects with conditions that affect the absorption, metabolism, or passage of drugs out of the body, (e.g., sprue, celiac disease, Crohn's disease, colitis, or liver, kidney, or thyroid conditions);

4. Subjects with any history of alcohol or substance abuse (including a positive drug screen test);

5. Subjects that currently have or have a history of hypertension;

6. Subjects with a known hypersensitivity to any local anesthetic drug;

7. Subjects with a history of benign prostatic hyperplasia or difficulty in urination;

8. Subjects with a hematocrit level below the normal range on the screening laboratory examination;

9. Subjects with any clinically significant abnormal lab result (as judged by the Principal Investigator);

10. An abnormal ECG at screening including PR>200 ms, QRS>110 ms, QTcF<380 or >400 ms, lead II T wave abnormalities. Non-specific T wave abnormalities in leads other than lead II are permissible if not accompanied by any other morphological abnormalities.

11. Subjects with any condition or history felt by the Investigator to place the subject at increased risk;

12. Subjects who have smoked or chewed tobacco-containing substances within 6 months prior to the start of the study;

13. Subjects judged by the Investigator to be unable or unwilling to comply with the requirements of the protocol;

14. Subjects who have used an investigational drug within 30 days prior to entering the study;

15. Subjects who have donated blood within 3 months prior to the start of the study (including blood donation related to the surgical procedure);

16. Subjects who have previously participated in the trial;

17. Subjects who are members of the study site staff directly involved with the study or a relative of the Sponsor or other personnel involved with the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

PainReform LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Naveh

Role: STUDY_CHAIR

PainReform LTD

Locations

Hadassah University Hospital

Jerusalem, , Israel

Countries

Israel

Other Identifiers

PRF108-POC99-09

Identifier Type: -

Identifier Source: org_study_id