PainPhase 1/2NCT00883194

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

A Phase 1/2 study testing PRF-108, Ropivacaine and PRF-110 in people with Pain, run by PainReform LTD at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: PRF-108, Ropivacaine and PRF-110
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteIsrael
Study dates: Oct 2010to Apr 2011
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 17Show fewer

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);
Subjects who have previously participated in the trial;
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.

Trial locations and contacts

1 site in 1 country.

Israel1 site

Hadassah University Hospital
Jerusalem

Other trials in Israel

About this study

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

Read the detailed description

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
Being tested: PRF-108, Placebo, Ropivacaine, PRF-110
Keywords: Experimental Pain Model
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRF-108Drug
Ropivacaine
PlaceboDrug
PRF-108 Placebo
RopivacaineDrug
Solution
PRF-110Drug
Also called ropivacaine

Study groups in NCT00883194
Study group	Role	What they receive
1	Experimental	PRF-108 Gel, 4% ropivacaine Receives: Drug: PRF-108
2	Placebo comparator	PRF-108 Gel, Vehicle Receives: Drug: Placebo
3	Active comparator	Ropivacaine Solution 0.5% Receives: Drug: Ropivacaine
PRF-110, 4%	Experimental	PRF-110, 4% ropivacaine Receives: Drug: PRF-110

What is being measured

The primary outcome is the main question the study is designed to answer.

The duration of analgesia
Measured: 3 days

Secondary outcomes (1)

PRF-108 and PRF-110 Safety
Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Apr 2011

First posted17 Apr 2009 (estimated)
Study startOct 2010
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00883194
Sponsor's protocol ID: PRF108-POC99-09
Status last verified: Nov 2020
First submitted: 16 Apr 2009
Last updated: 16 Nov 2020
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00883194
Acronym / sponsor ID: PRF108-POC99-09
Conditions: Pain
Keywords: Experimental Pain Model
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: PainReform LTDIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 17 Apr 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: PRF-108PRF-108 Gel, 4% ropivacaine
2	Placebo comparator	Drug: PlaceboPRF-108 Gel, Vehicle
3	Active comparator	Drug: RopivacaineRopivacaine Solution 0.5%
PRF-110, 4%	Experimental	Drug: PRF-110PRF-110, 4% ropivacaine

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (17 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PRF-108Ropivacaine	Drug	1
PlaceboPRF-108 Placebo	Drug	2
RopivacaineSolution	Drug	3
PRF-110Also: ropivacaine	Drug	PRF-110, 4%

Primary outcome

The duration of analgesia
Time frame: 3 days

1 secondary outcome

PRF-108 and PRF-110 Safety
Time frame: 3 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Naveh study chair

PainReform LTD

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PRF-108, Ropivacaine and PRF-110 in people with Pain, run by PainReform LTD at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The duration of analgesia (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00883194.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.