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

BioQ Pharma, Inc.11 sites in 1 country132 target enrollmentMarch 13, 2017

ConditionsPain, Postoperative

InterventionsPlacebos Ropivacaine

DrugsRopivacaine Placebos

Overview

Phase: Phase 3
Intervention: Placebos
Conditions: Pain, Postoperative
Sponsor: BioQ Pharma, Inc.
Enrollment: 132
Locations: 11
Primary Endpoint: Cumulative analgesic effect
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 13, 2017

End Date

August 10, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

BioQ Pharma, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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
•Weigh greater than 100 kg (220 lbs).
•Have made a plasma donation within 7 days prior to Day -
•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

Arms & Interventions

Placebo

Naropin® (ropivacaine HCl Injection, USP) bolus + placebo infusion (normal saline) - "Placebo treatment arm"

Intervention: Placebos

Ropivacaine 0.2%

Naropin® (ropivacaine HCl Injection, USP) bolus + Ropivacaine 0.2% Pre-Filled Dispenser infusion - "Ropivacaine Infusion treatment arm"

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Cumulative analgesic effect

Time Frame: 48 hours

Secondary Outcomes

Overall safety using descriptive statistics of the evaluation of physical exam, vital signs, clinical laboratory tests, and treatment-emergent adverse events(7 days)
Use of other analgesics(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(7 days)
Analgesic effect at specified intervals(48 hours)