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Trial record 23 of 59591 for:    Placebo

A Randomized Double-Blind, Multi-Dose, Placebo Controlled Study of Acetaminophen Injection Post Surgical Dental Pain

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ClinicalTrials.gov Identifier: NCT04018612
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Nevakar, LLC

Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date July 12, 2019
Actual Study Start Date  ICMJE April 25, 2019
Estimated Primary Completion Date July 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
To assess efficacy of 1300 mg of intravenous acetaminophen and intravenous acetaminophen 1000mg to placebo in post surgical dental pain through 11 point Likert Scale [ Time Frame: 0 to 24 hours ]
Treatment comparisons that will be performed are:
  • IV APAP 1300 mg q8h versus Placebo
  • IV APAP 1000 mg q6h versus Placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • Pharmacokinetics study of acetaminophen injection post surgical dental pain [ Time Frame: 0 to 24 Hours ]
    The pharmacokinetics of of 1300 mg of intravenous acetaminophen and intravenous acetaminophen 1000mg to placebo. Measurements will include CMax
  • Pharmacokinetics study of acetaminophen injection post surgical dental pain [ Time Frame: 0 to 24 Hours ]
    The pharmacokinetics of of 1300 mg of intravenous acetaminophen and intravenous acetaminophen 1000mg to placebo. Measurements will include AUC
  • Pharmacokinetics study of acetaminophen injection post surgical dental pain [ Time Frame: 0 to 24 Hours ]
    The pharmacokinetics of of 1300 mg of intravenous acetaminophen and intravenous acetaminophen 1000mg to placebo. Measurements will include TMAX
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2019)
Safety study of acetaminophen injection post surgical dental pain [ Time Frame: 0 to 24 hours ]
The incidence of the most common >5% adverse events will be compared between 1300 mg of intravenous acetaminophen and intravenous acetaminophen 1000mg to placebo
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Randomized Double-Blind, Multi-Dose, Placebo Controlled Study of Acetaminophen Injection Post Surgical Dental Pain
Official Title  ICMJE A Randomized, Double-Blind, Multi-Dose, Single-Site, Placebo- and Active-Controlled, Efficacy, Tolerability, Safety and Pharmacokinetic Study of Two Different Dosing Regimens of Acetaminophen Injection in Post-Surgical Dental Pain.
Brief Summary To assess the safety, tolerability, analgesic, efficacy and pharmacokinetics of acetaminophen 1300mg (IV APAP) dosed every eight hours relative to placebo and acetaminophen 1000mg (IV APAP) dosed every 6 hours relative to placebo over a 24 hour period in patient experiencing moderate to server pain following the surgical removal of third molar.
Detailed Description This will be a randomized, double-blind, single-site, placebo-controlled, parallel-group study to assess similarities in safety, tolerability, efficacy, and pharmacokinetics of 1300 mg of injectable acetaminophen given in three doses, each 8 hours apart, relative to placebo, and 1000 mg of injectable acetaminophen given in four doses, each 6 hours apart, relative to placebo over a 24-hour period in patients experiencing moderate to severe postsurgical pain within 7 hours following surgical removal of 2 or more molars
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
IV APAP 1300 mg q8h versus Placebo IV APAP 1000 mg q6h versus Placebo
Masking: Double (Participant, Investigator)
Masking Description:
Double Blind, Placebo controlled
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Postoperative
  • Dental Pain
Intervention  ICMJE
  • Drug: Ofirmev Injectable Product (Acetaminophen)
    Ofirmev Injectable Product (Acetaminophen)
  • Other: Placebo
    IV Saline
Study Arms  ICMJE
  • Active Comparator: IV Acetaminophen 1300 mg
    IV Acetaminophen 1300 mg Post Op q8h
    Intervention: Drug: Ofirmev Injectable Product (Acetaminophen)
  • Active Comparator: IV Acetaminophen 1000 mg
    IV Acetaminophen 100 mg Post Op q6h
    Intervention: Drug: Ofirmev Injectable Product (Acetaminophen)
  • Placebo Comparator: Placebo
    IV Placebo Post Op
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2019)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 26, 2019
Estimated Primary Completion Date July 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients must be capable of reading, comprehending, and signing the informed consent/assent form;
  2. Male and female patients between 17-55 years of age;
  3. Body Mass Index (BMI) ≤35.0 kg/m2
  4. Body weight of >50 kg
  5. Patients are ASA Category I or II and are in good physical health as judged by a thorough history and physical examination;
  6. Patients without infections in the area of the impacted teeth;
  7. Patients must agree to refrain from ingesting any systemic or applying any topical analgesic medication for 3 days or 5 half-lives of the drug prior to and during the study;
  8. No alcohol for a minimum of 24 hours prior to the surgery;
  9. Female patients must be of non-child bearing potential, defined as postmenopausal for more than 1 year or surgically sterile (hysterectomy, tubal ligation/occlusion) or practicing an acceptable method of contraception (hormonal oral, patch, or implant, double barrier method, intrauterine device, vasectomized or same sex partner, or abstinence). Patients using hormonal birth control must have been on a stable dose of treatment for at least 30 days and received at least 1 cycle of treatment prior to randomization. At Screening and at the day of surgery, all females of childbearing potential must have a negative (serum at screening and urine on day of surgery 1) pregnancy test and not be breastfeeding;
  10. Patients must have a negative urine drug screen for drugs of abuse at Screening and on the day of surgery. At the discretion of the Principal Investigator, a positive drug screen result may be permitted if the patient has been on a stable dose of an allowed medication for >30 days;
  11. Patients who are scheduled to undergo the surgical removal of up to 4 third molars of which at least two have to be mandibular molars with a difficulty rating of 4 or 5 and meeting the following criteria:

    • two full bony impactions
    • two partial bony impactions
    • one full bony impaction in combination with one partial bony impaction (see Appendix 1 for Impaction Difficulty Rating Scale);
  12. Patients able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon the research site's judgment.

Exclusion Criteria:

  1. Patients with a history of any significant medical condition that, in the opinion of the Principal Investigator or his designee, would place the patient at increased risk such as: hepatic, renal, endocrine, cardiac, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders, including glaucoma, diabetes, emphysema, and chronic bronchitis;
  2. Patients with a history of any type of malignancy within the past 5 years other than minor skin related cancers;
  3. Patients with a history of alcohol or substance abuse in the past three years according to DSM V and who do not satisfy Inclusion Criteria 10 (including a positive urine drug screen test);
  4. Patients with a known allergy or hypersensitivity to any local anesthetic drug, acetaminophen, ibuprofen, or other NSAIDS;
  5. Patients who are taking any concomitant medications that might confound assessments of pain relief, such as psychotropic drugs, antidepressants, sedative hypnotics or any analgesics taken within three days or five times of their elimination half-lives, whichever is longer. Selective serotonin reuptake inhibitors (SSRIs) and selective noradrenaline reuptake inhibitors (SNRIs) are permitted if the patient has been on a stable dose for at least 30 days prior to screening;
  6. Patients who have smoked or chewed tobacco-containing substances within 48 hours prior to the day of surgery;
  7. Patients judged by the Principal Investigator to be unable or unwilling to comply with the requirements of the protocol;
  8. Patients who have used an investigational drug within 30 days prior to the screening day or have previously participated in any Nevakar trial;
  9. Patients who have donated blood within 3 months prior to the screening day;
  10. Patients who are employees or relatives of employees of JBR Clinical Research or Nevakar, Inc.
  11. Patients with liver function tests (ALT, AST) that are above the normal reference range.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Michelle Novello 908-367-7400 ext 7472 mnovello@nevakar.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04018612
Other Study ID Numbers  ICMJE CP-NVK009-0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nevakar, LLC
Study Sponsor  ICMJE Nevakar, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eric Lang, MD Nevakar, Inc
PRS Account Nevakar, LLC
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP