Pain, PostoperativePhase 3NCT02959476
Ropivacaine 0.2% Pre-Filled Dispenser for the Treatment of Postsurgical Pain in Patients Undergoing Cesarean Delivery
A Phase 3 study testing Ropivacaine in people with Pain, Postoperative, run by BioQ Pharma, Inc. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 11 sitesUnited States
- Study dates
- 13 Mar 2017to 10 Aug 2018
- Phase
- Phase 3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 17Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Compass Clinical Trial
Beaumont, Texas, 77702
MedPharmics, LLC
Biloxi, Mississippi, 39531
Clinical Research Associates, Inc.
Birmingham, Alabama, 35205
Physician's Research Options, LLC- Corner Canyon OB/GYN
Draper, Utah, 84020
Duke University Medical Center
Durham, North Carolina, 27606
Clinical Research Prime
Idaho Falls, Idaho, 83404
West Virginia University
Morgantown, West Virginia, 26506
University of California, Irvine
Orange, California, 92868
Health Sciences Center- University of Utah
Salt Lake City, Utah, 84112
Shoals Medical Trials, Inc.
Sheffield, Alabama, 35660
Vision Clinical Research
Wellington, Florida, 33414
About this study
Official title: 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.
- Conditions
- Pain, Postoperative
- Being tested
- Ropivacaine, Placebos
- Keywords
- Postoperative pain, Postsurgical pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Anesthetic
PlacebosDrug
Inactive comparator
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine 0.2% | Experimental | Naropin® (ropivacaine HCl Injection, USP) bolus + Ropivacaine 0.2% Pre-Filled Dispenser infusion - "Ropivacaine Infusion treatment arm" Receives: Drug: Ropivacaine |
| Placebo | Placebo comparator | Naropin® (ropivacaine HCl Injection, USP) bolus + placebo infusion (normal saline) - "Placebo treatment arm" Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative analgesic effect
Measured: 48 hours
Secondary outcomes (4)
Use of other analgesics
Measured: 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
Measured: 7 days
Overall safety using descriptive statistics of the evaluation of physical exam, vital signs, clinical laboratory tests, and treatment-emergent adverse events
Measured: 7 days
Analgesic effect at specified intervals
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start13 Mar 2017
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioQ Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959476
- Sponsor's protocol ID
- 94006184
- Status last verified
- Apr 2018
- First submitted
- 4 Nov 2016
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02959476
- Acronym / sponsor ID
- 94006184
- Conditions
- Pain, Postoperative
- Keywords
- Postoperative pain, Postsurgical pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- BioQ Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 9 Nov 2016 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine 0.2% | Experimental | Drug: RopivacaineNaropin® (ropivacaine HCl Injection, USP) bolus + Ropivacaine 0.2% Pre-Filled Dispenser infusion - "Ropivacaine Infusion treatment arm" |
| Placebo | Placebo comparator | Drug: PlacebosNaropin® (ropivacaine HCl Injection, USP) bolus + placebo infusion (normal saline) - "Placebo treatment arm" |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| RopivacaineAnesthetic | Drug | Ropivacaine 0.2% |
| PlacebosInactive comparator | Drug | Placebo |
Primary outcome
Cumulative analgesic effect
Time frame: 48 hours
4 secondary outcomes
Use of other analgesics
Time frame: 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
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
Analgesic effect at specified intervals
Time frame: 48 hours
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 14 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine in people with Pain, Postoperative, run by BioQ Pharma, Inc. at 11 sites in United States.
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 8 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 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Cumulative analgesic effect (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2018.