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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PainReform LTD
ClinicalTrials.gov Identifier:
NCT00883194
First received: April 16, 2009
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Pain
Drug: PRF-108
Drug: Placebo
Drug: Ropivacaine
Drug: PRF-110
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-center, Randomized, Placebo-controlled, Double-blind, Single-dose, Efficacy of PRF-108 4% and PRF-110 4% Versus Ropivacaine Solution 0.5% in an Experimental Pain Model

Resource links provided by NLM:


Further study details as provided by PainReform LTD:

Primary Outcome Measures:
  • The duration of analgesia [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PRF-108 and PRF-110 Safety [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PRF-108 Gel, 4%
Drug: PRF-108
Ropivacaine
Placebo Comparator: 2
PRF-108 Gel, Vehicle
Drug: Placebo
PRF-108 Placebo
Active Comparator: 3
Ropivacaine Solution 0.5%
Drug: Ropivacaine
Solution
Experimental: PRF-110, 4%
PRF-110, 4%
Drug: PRF-110
Other Name: ropivacaine

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883194

Locations
Israel
Hadassah University Hospital
Jerusalem, Israel
Sponsors and Collaborators
PainReform LTD
Investigators
Study Chair: Michael Naveh PainReform LTD
  More Information

No publications provided

Responsible Party: PainReform LTD
ClinicalTrials.gov Identifier: NCT00883194     History of Changes
Other Study ID Numbers: PRF108-POC99-09
Study First Received: April 16, 2009
Last Updated: September 12, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by PainReform LTD:
Experimental Pain Model

Additional relevant MeSH terms:
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014