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

Primary Purpose

Dental Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pre-Op pregabalin
Pre-Op Placebo 1
Post-Op pregabalin
Post-Op Placebo 1
Post-Op Placebo 2
Post-Op acetaminophen
Sponsored by
Nevakar, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pain

Eligibility Criteria

17 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

  • Jean Brown Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

Pre-op Placebo 1; Post-op Placebo 1; Post-op Placebo 2

Pre-op Placebo 1; Post-op Placebo 2; Post-op acetaminophen.

Pre-op Placebo 1; Post-op pregabalin; Post-op Placebo 2.

Pre-op Placebo 1; Post-op pregabalin Post-op acetaminophen.

Pre-op pregabalin; Post-op Placebo 1; Post-op acetaminophen.

Outcomes

Primary Outcome Measures

Sum Pain Intensity Difference Scores
Beginning post-surgery (at initiation of Dose 2), Pain Intensity was 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). Time weighted sum pain intensity difference scores are reported over 0 to 24 hours. Last observation carried forward method was used.
Total Pain Relief Measure
Beginning post-surgery (at initiation of Dose 2), Pain Relief was 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). Time-weighted sum pain total pain relief scores over 24 hours is reported Last observation carried forward method was used.

Secondary Outcome Measures

Number of Participants With Differing Patient Global Evaluation Scores
Patient global evaluation was self-reported at time of first rescue or at 12.25 hours post-surgery, whichever was first, using a 0-4 categorical rating scale of: (0) poor, (1) fair, (2) good, (3) very good, and (4) excellent. The number of participants with differing patient global evaluation scores were reported.
Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After Dose 2
Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of FPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2.
Cumulative Number of Participants With Onset of Meaning Pain Relief (MPR) Confirmed at 24 Hours After Dose 2
Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of MPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2.

Full Information

First Posted
July 18, 2018
Last Updated
October 25, 2021
Sponsor
Nevakar, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03652818
Brief Title
Dental Pain Study of Analgesics in Patients Undergoing Molar Removal
Acronym
NVK009-0001
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
September 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nevakar, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Pre-op Placebo 1; Post-op Placebo 1; Post-op Placebo 2
Arm Title
Group B
Arm Type
Experimental
Arm Description
Pre-op Placebo 1; Post-op Placebo 2; Post-op acetaminophen.
Arm Title
Group C
Arm Type
Experimental
Arm Description
Pre-op Placebo 1; Post-op pregabalin; Post-op Placebo 2.
Arm Title
Group D
Arm Type
Experimental
Arm Description
Pre-op Placebo 1; Post-op pregabalin Post-op acetaminophen.
Arm Title
Group E
Arm Type
Experimental
Arm Description
Pre-op pregabalin; Post-op Placebo 1; Post-op acetaminophen.
Intervention Type
Drug
Intervention Name(s)
Pre-Op pregabalin
Intervention Description
Pre-op pregabalin will be administered 60 min prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Pre-Op Placebo 1
Other Intervention Name(s)
pre-op placebo
Intervention Description
Placebo 1 will be administered 60 min prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Post-Op pregabalin
Intervention Description
Post-op pregabalin will be administered Post-operatively.
Intervention Type
Drug
Intervention Name(s)
Post-Op Placebo 1
Intervention Description
Placebo 1 will be administered post-operatively.
Intervention Type
Drug
Intervention Name(s)
Post-Op Placebo 2
Intervention Description
Placebo 2 will be administered post-operatively.
Intervention Type
Drug
Intervention Name(s)
Post-Op acetaminophen
Intervention Description
Acetaminophen will be administered Post-operatively.
Primary Outcome Measure Information:
Title
Sum Pain Intensity Difference Scores
Description
Beginning post-surgery (at initiation of Dose 2), Pain Intensity was 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). Time weighted sum pain intensity difference scores are reported over 0 to 24 hours. Last observation carried forward method was used.
Time Frame
0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)
Title
Total Pain Relief Measure
Description
Beginning post-surgery (at initiation of Dose 2), Pain Relief was 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). Time-weighted sum pain total pain relief scores over 24 hours is reported Last observation carried forward method was used.
Time Frame
0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)
Secondary Outcome Measure Information:
Title
Number of Participants With Differing Patient Global Evaluation Scores
Description
Patient global evaluation was self-reported at time of first rescue or at 12.25 hours post-surgery, whichever was first, using a 0-4 categorical rating scale of: (0) poor, (1) fair, (2) good, (3) very good, and (4) excellent. The number of participants with differing patient global evaluation scores were reported.
Time Frame
Upto 12.25 hours
Title
Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After Dose 2
Description
Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of FPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2.
Time Frame
0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours
Title
Cumulative Number of Participants With Onset of Meaning Pain Relief (MPR) Confirmed at 24 Hours After Dose 2
Description
Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of MPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2.
Time Frame
0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Somberg, MD
Organizational Affiliation
Nevakar, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

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Dental Pain Study of Analgesics in Patients Undergoing Molar Removal

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