Ropivacaine 0.2% Pre-Filled Dispenser for the Treatment of Postsurgical Pain in Patients Undergoing Cesarean Delivery

August 10, 2018 updated by: BioQ Pharma, Inc.

A Double Blind, Multi-center, Randomized, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Ropivacaine 0.2% Pre-Filled Dispenser for the Treatment of Postsurgical Pain in Patients Undergoing Cesarean Delivery

This study evaluates a Ropivacaine 0.2% Pre-Filled Dispenser in the treatment of post-surgical pain in patients undergoing Cesarean delivery. Half of the patients will receive Ropivicaine and half will receive placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Clinical Research Associates, Inc.
      • Sheffield, Alabama, United States, 35660
        • Shoals Medical Trials, Inc.
    • California
      • Orange, California, United States, 92868
        • University of California, Irvine
    • Florida
      • Wellington, Florida, United States, 33414
        • Vision Clinical Research
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Clinical Research Prime
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
        • MedPharmics, LLC
    • North Carolina
      • Durham, North Carolina, United States, 27606
        • Duke University Medical Center
    • Texas
      • Beaumont, Texas, United States, 77702
        • Compass Clinical Trial
    • Utah
      • Draper, Utah, United States, 84020
        • Physician's Research Options, LLC- Corner Canyon OB/GYN
      • Salt Lake City, Utah, United States, 84112
        • Health Sciences Center- University of Utah
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Complete the informed consent process as documented by a signed informed consent form (ICF).
  • Be in generally good health and classified as either PS-1 or PS-2 by the American Society of Anesthetists (ASA) Physical Status Classification System.
  • Have a single birth pregnancy. Can be parous or nulliparous.
  • Be scheduled for a Cesarean Delivery
  • Subjects undergoing emergency Cesarean Delivery will not be eligible for participation in this study.
  • In the event a subject signs the ICF (but has not been randomized), has a C section planned and then has an emergency C section delivery, this subject will be considered a screen failure.
  • In the unlikely event a subject signs the ICF and is randomized into the study, has a C section planned and then has an emergency C section delivery, this subject will continue in the study as planned.
  • Be willing to complete the pain assessments according to the protocol and return to clinic as scheduled, as needed.

Exclusion Criteria:

  • Have an uncontrolled medical condition, serious intercurrent illness, clinically significant general health condition, or extenuating circumstance that may significantly decrease study compliance or otherwise preclude their participation in the study.
  • Have a clinically significant abnormal electrocardiogram (ECG) at screening as determined by the Investigator.
  • Have a history of any medical condition or surgical procedure that would alter the absorption, distribution, metabolism, or excretion of ropivacaine.
  • Have, in the opinion of the investigator, a clinically significant abnormality in their clinical laboratory values (urinalysis, hematology and chemistry) at screening.
  • Have made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to Day 1.
  • Weigh greater than 100 kg (220 lbs).
  • Have made a plasma donation within 7 days prior to Day -1.
  • Have a known allergy or hypersensitivity to anesthetics (eg. Ropivacaine), acetaminophen, or non-steroidal anti inflammatory drugs (NSAIDs, eg, ibuprofen or naproxen, ketorolac).

  • Not be able or willing to discontinue the prohibited medications listed below within the allotted time before surgery and throughout the duration of their participation in the study.

    • monoamine oxidase inhibitors (MAOIs) within the past 30 days
    • anticonvulsants, tricyclic antidepressants (TCAs), neuroleptics, serotonin-norepinephrine reuptake inhibitors (SNRIs), as well as selective serotonin reuptake inhibitors (SSRIs) (unless SSRIs have been prescribed for depression and/or anxiety and subjects have been on a stable dose for at least 30 days prior to the screening visit);
    • Corticosteroids: Oral and injectable corticosteroids must be discontinued 3 months prior to surgery; nasal, inhaled and topical corticosteroids will be allowed;
  • Use concurrent therapy that could interfere with the evaluation of efficacy or safety parameters in the opinion of the investigator (eg, any drugs, in the investigator's opinion, that may exert significant analgesic properties), except for rescue medications.
  • Have a history of seizures or history of serious head injury.
  • Must not be a member of a vulnerable population as defined by the Code of Federal Regulations Title 45, Part 46, Delivery 46.111(b), including but not limited to employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study, or of the Sponsor, or of the Clinical Research Organization.
  • Have previously participated in a clinical trial using ropivacaine.
  • Have a history of major mental illness that in the opinion of the Investigator may affect the ability of the subject to participate in the study. Institutionalized subjects will not be eligible for participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ropivacaine 0.2%
Naropin® (ropivacaine HCl Injection, USP) bolus + Ropivacaine 0.2% Pre-Filled Dispenser infusion - "Ropivacaine Infusion treatment arm"
Drug: Ropivacaine
Anesthetic
Placebo Comparator: Placebo
Naropin® (ropivacaine HCl Injection, USP) bolus + placebo infusion (normal saline) - "Placebo treatment arm"
Drug: Placebos
Inactive comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative analgesic effect
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Use of other analgesics
Time Frame: 48 hours
48 hours
Local safety and tolerability using descriptive statistics of the evaluation of physical exams, wound healing and treatment-emergent adverse events local to the surgical wound
Time Frame: 7 days
7 days
Overall safety using descriptive statistics of the evaluation of physical exam, vital signs, clinical laboratory tests, and treatment-emergent adverse events
Time Frame: 7 days
7 days
Analgesic effect at specified intervals
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioQ Pharma, Inc.

Collaborators

Health Decisions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2017

Primary Completion (Actual)

August 10, 2018

Study Completion (Actual)

August 10, 2018

Study Registration Dates

First Submitted

November 4, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 9, 2016

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 94006184

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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