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Dental Pain Study of Analgesics in Patients Undergoing Molar Removal (NVK009-0001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652818
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Nevakar, LLC

Brief Summary:
  • Accessing the efficacy and safety of pregabalin when used alone and in combo with acetaminophen in a dental pain model.
  • To test whether pre-operative dose of pregabalin increases the time to significant post-operative pain (NRS ≥ 5), and hence time to first analgesia consumed post-operatively.

Condition or disease Intervention/treatment Phase
Dental Pain Drug: Pre-Op pregabalin Drug: Pre-Op Placebo 1 Drug: Post-Op pregabalin Drug: Post-Op Placebo 1 Drug: Post-Op Placebo 2 Drug: Post-Op acetaminophen Phase 2

Detailed Description:

This is a 5 arm randomized, double-blind, parallel group, single-center, placebo-controlled study to evaluate the efficacy and safety of pregabalin-acetaminophen combination in the prevention and treatment of post-surgical dental pain in healthy patients.

Subjects in every treatment arm will receive a dose 60 min prior to surgery. It is not required to receive a post-operative dose if patient does not feel pain at a scale of NRS≥ 5. Dose 2 will be given post-surgically when patients report at least moderate pain on the categorical scale and a score of ≥5 on 0-10 PI-NRS. Subsequent to dose 2, patients can request rescue analgesic at any time.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The sponsor, patients, investigators and study staff involved in the protocol procedures or those involved in data collection, data entry, data analysis will be blinded.
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Parallel Group, Single-center, Placebo-controlled Study to Evaluate Efficacy and Safety of Analgesic Combo in Prevention and Treatment of Post-surgical Dental Pain in Healthy Subjects
Actual Study Start Date : June 15, 2018
Actual Primary Completion Date : September 20, 2018
Actual Study Completion Date : September 20, 2018

Arm Intervention/treatment
Experimental: Group A

Pre-op Placebo 1;

Post-op Placebo 1;

Post-op Placebo 2

Drug: Pre-Op Placebo 1
Placebo 1 will be administered 60 min prior to surgery.
Other Name: pre-op placebo

Drug: Post-Op Placebo 1
Placebo 1 will be administered post-operatively.

Drug: Post-Op Placebo 2
Placebo 2 will be administered post-operatively.

Experimental: Group B

Pre-op Placebo 1;

Post-op Placebo 2;

Post-op acetaminophen.

Drug: Pre-Op Placebo 1
Placebo 1 will be administered 60 min prior to surgery.
Other Name: pre-op placebo

Drug: Post-Op Placebo 1
Placebo 1 will be administered post-operatively.

Drug: Post-Op acetaminophen
Acetaminophen will be administered Post-operatively.

Experimental: Group C

Pre-op Placebo 1;

Post-op pregabalin;

Post-op Placebo 2.

Drug: Pre-Op Placebo 1
Placebo 1 will be administered 60 min prior to surgery.
Other Name: pre-op placebo

Drug: Post-Op pregabalin
Post-op pregabalin will be administered Post-operatively.

Drug: Post-Op Placebo 2
Placebo 2 will be administered post-operatively.

Experimental: Group D

Pre-op Placebo 1;

Post-op pregabalin

Post-op acetaminophen.

Drug: Pre-Op Placebo 1
Placebo 1 will be administered 60 min prior to surgery.
Other Name: pre-op placebo

Drug: Post-Op pregabalin
Post-op pregabalin will be administered Post-operatively.

Drug: Post-Op acetaminophen
Acetaminophen will be administered Post-operatively.

Experimental: Group E

Pre-op pregabalin;

Post-op Placebo 1;

Post-op acetaminophen.

Drug: Pre-Op pregabalin
Pre-op pregabalin will be administered 60 min prior to surgery.

Drug: Post-Op Placebo 1
Placebo 1 will be administered post-operatively.

Drug: Post-Op acetaminophen
Acetaminophen will be administered Post-operatively.




Primary Outcome Measures :
  1. Pain Intensity Measure [ Time Frame: 24 Hours ]
    Beginning post-surgery (at initiation of Dose 2), Pain Intensity will be self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be).

  2. Pain Relief Measure [ Time Frame: 24 Hours ]
    Beginning post-surgery (at initiation of Dose 2), Pain Relief will be self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be).


Secondary Outcome Measures :
  1. Patient Global Evaluation Measure [ Time Frame: 24 Hours ]
    Patient global evaluation will be self-reported over 24 hours, using a 0-4 categorical rating scale of: (0) poor, (1) fair, (2) good, (3) very good, and (4) excellent.

  2. First Perceptible Relief (FPR) Measure [ Time Frame: 24 Hours ]
    Beginning post-surgery (at initiation of Dose 2), patients will be given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time will be noted in the patient record.

  3. Meaningful Perceptible Relief (MPR) Measure [ Time Frame: 24 Hours ]
    Beginning post-surgery (at initiation of Dose 2), patients will be given a second stopwatch and asked to press the stopwatch if and when they feel any meaningful perceptible relief; a record of the time will be noted in the patient record.



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who are scheduled to undergo the surgical removal of up to 4 third molars of which at least 2 have to be mandibular molars with a difficulty rating of 4 or 5.
  • Patient must have a negative urine drug screen for drugs of abuse (including tobacco) at screening and at the day of surgery.
  • No alcohol for a minimum of 1 day prior to the surgery.

Exclusion Criteria:

  • Patients should not be experiencing oral infections or symptoms of concomitant illness at the time of a scheduled surgery.
  • Patients with a history of any type of malignancy within the past 5 years other than minor skin related cancers.
  • Patients who currently have or have had a history of uncontrolled hypertension.
  • Patients with a known allergy or hypersensitivity to any local anesthetic drug, NSAIDs, gabapentin or pregabalin;.
  • Patients with conditions that affect the absorption, metabolism, or passage of drugs out of the body (e.g., sprue, celiac disease, crohn's disease, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652818


Locations
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United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Nevakar, LLC
Investigators
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Study Director: Kenneth Somberg, MD Nevakar, LLC

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Responsible Party: Nevakar, LLC
ClinicalTrials.gov Identifier: NCT03652818    
Other Study ID Numbers: CP-NVK009-0001
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Pregabalin
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs