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

NCT00883194 | Completed Phase 1

• 1 other identifier: PRF108-POC99-09
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Experimental Pain Model

Outcome Measures

Primary Outcomes (1)

• The duration of analgesia

  3 days

Secondary Outcomes (1)

• PRF-108 and PRF-110 Safety

  3 days

Study Arms (4)

1

EXPERIMENTAL

PRF-108 Gel, 4% ropivacaine

Drug: PRF-108

2

PLACEBO COMPARATOR

PRF-108 Gel, Vehicle

Drug: Placebo

3

ACTIVE COMPARATOR

Ropivacaine Solution 0.5%

Drug: Ropivacaine

PRF-110, 4%

EXPERIMENTAL

PRF-110, 4% ropivacaine

Drug: PRF-110

Interventions

PRF-108 DRUG

Ropivacaine

1

Placebo DRUG

PRF-108 Placebo

2

Ropivacaine DRUG

Solution

3

PRF-110 DRUG

Also known as: ropivacaine

PRF-110, 4%

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects between 18-60 years of age;
• Subjects are within ±10% of ideal body weight/height (based on frame size) as given by the Metropolitan Life Insurance Tables;
• 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;
• 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;
• Subjects can tolerate a 0.5mL injection of saline in the lower back area.
• The subject is capable of reading, comprehending, and signing the informed consent form.

You may not qualify if:

• 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;
• Subjects with a history of any type of cancer;
• 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);
• Subjects with any history of alcohol or substance abuse (including a positive drug screen test);
• Subjects that currently have or have a history of hypertension;
• Subjects with a known hypersensitivity to any local anesthetic drug;
• Subjects with a history of benign prostatic hyperplasia or difficulty in urination;
• Subjects with a hematocrit level below the normal range on the screening laboratory examination;
• Subjects with any clinically significant abnormal lab result (as judged by the Principal Investigator);
• 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.
• Subjects with any condition or history felt by the Investigator to place the subject at increased risk;
• Subjects who have smoked or chewed tobacco-containing substances within 6 months prior to the start of the study;
• Subjects judged by the Investigator to be unable or unwilling to comply with the requirements of the protocol;
• Subjects who have used an investigational drug within 30 days prior to entering the study;
• Subjects who have donated blood within 3 months prior to the start of the study (including blood donation related to the surgical procedure);

Sponsors & Collaborators

• PainReform LTD: lead

Study Sites (1)

Hadassah University Hospital

Jerusalem, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Michael Naveh

  PainReform LTD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 17, 2009
• Study Start: October 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

IL (1)