Dental PainPhase 2NVK009-0001NCT03652818

Dental Pain Study of Analgesics in Patients Undergoing Molar Removal

A Phase 2 study testing Pre-Op pregabalin and Post-Op pregabalin in people with Dental Pain, run by Nevakar, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 17 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Dental Pain
What is being tested?: Pre-Op pregabalin and Post-Op pregabalin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 115 participants
Where: 1 siteUnited States
Study dates: 15 Jun 2018to 20 Sep 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 17 to 55 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.

Who cannot join

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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

Jean Brown Research
Salt Lake City, Utah, 84124

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Dental Pain
Being tested: Pre-Op pregabalin, Pre-Op Placebo 1, Post-Op pregabalin, Post-Op Placebo 1, Post-Op Placebo 2
Medical subject headings: Toothache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pre-Op pregabalinDrug
Pre-op pregabalin will be administered 60 min prior to surgery.
Pre-Op Placebo 1Drug
Also called pre-op placebo
Placebo 1 will be administered 60 min prior to surgery.
Post-Op pregabalinDrug
Post-op pregabalin will be administered Post-operatively.
Post-Op Placebo 1Drug
Placebo 1 will be administered post-operatively.
Post-Op Placebo 2Drug
Placebo 2 will be administered post-operatively.
Post-Op acetaminophenDrug
Acetaminophen will be administered Post-operatively.

Study groups in NCT03652818
Study group	Role	What they receive
Group A	Experimental	Pre-op Placebo 1; Post-op Placebo 1; Post-op Placebo 2 Receives: Drug: Pre-Op Placebo 1; Drug: Post-Op Placebo 1; Drug: Post-Op Placebo 2
Group B	Experimental	Pre-op Placebo 1; Post-op Placebo 2; Post-op acetaminophen. Receives: Drug: Pre-Op Placebo 1; Drug: Post-Op Placebo 1; Drug: Post-Op acetaminophen
Group C	Experimental	Pre-op Placebo 1; Post-op pregabalin; Post-op Placebo 2. Receives: Drug: Pre-Op Placebo 1; Drug: Post-Op pregabalin; Drug: Post-Op Placebo 2
Group D	Experimental	Pre-op Placebo 1; Post-op pregabalin Post-op acetaminophen. Receives: Drug: Pre-Op Placebo 1; Drug: Post-Op pregabalin; Drug: Post-Op acetaminophen
Group E	Experimental	Pre-op pregabalin; Post-op Placebo 1; Post-op acetaminophen. Receives: Drug: Pre-Op pregabalin; Drug: Post-Op Placebo 1; Drug: Post-Op acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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.
Measured: 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 outcomes (3)

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.
Measured: Upto 12.25 hours
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.
Measured: 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours
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.
Measured: 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 201820 Sep 2018

First posted29 Aug 2018
Study start15 Jun 2018
Primary completion20 Sep 2018
Study completion20 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dental PainStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03652818
Sponsor's protocol ID: CP-NVK009-0001
Acronym: NVK009-0001
Status last verified: Oct 2021
First submitted: 18 Jul 2018
Last updated: 23 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain

All Dental Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03652818
Acronym / sponsor ID: NVK009-0001 / CP-NVK009-0001
Conditions: Dental Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Nevakar, Inc.Industry (pharma, biotech, devices)
Study start: 15 Jun 2018 (actual)
Primary completion: 20 Sep 2018 (actual)
Study completion: 20 Sep 2018 (actual)
First posted: 29 Aug 2018 (actual)
Results: Posted 23 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Group A	Experimental	Drug: Pre-Op Placebo 1, Drug: Post-Op Placebo 1, Drug: Post-Op Placebo 2Pre-op Placebo 1; Post-op Placebo 1; Post-op Placebo 2
Group B	Experimental	Drug: Pre-Op Placebo 1, Drug: Post-Op Placebo 1, Drug: Post-Op acetaminophenPre-op Placebo 1; Post-op Placebo 2; Post-op acetaminophen.
Group C	Experimental	Drug: Pre-Op Placebo 1, Drug: Post-Op pregabalin, Drug: Post-Op Placebo 2Pre-op Placebo 1; Post-op pregabalin; Post-op Placebo 2.
Group D	Experimental	Drug: Pre-Op Placebo 1, Drug: Post-Op pregabalin, Drug: Post-Op acetaminophenPre-op Placebo 1; Post-op pregabalin Post-op acetaminophen.
Group E	Experimental	Drug: Pre-Op pregabalin, Drug: Post-Op Placebo 1, Drug: Post-Op acetaminophenPre-op pregabalin; Post-op Placebo 1; Post-op acetaminophen.

Who may qualify

Ages: 17 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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.)

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
Pre-Op pregabalinPre-op pregabalin will be administered 60 min prior to surgery.	Drug	Group E
Pre-Op Placebo 1Also: pre-op placeboPlacebo 1 will be administered 60 min prior to surgery.	Drug	Group A, Group B, Group C, Group D
Post-Op pregabalinPost-op pregabalin will be administered Post-operatively.	Drug	Group C, Group D
Post-Op Placebo 1Placebo 1 will be administered post-operatively.	Drug	Group A, Group B, Group E
Post-Op Placebo 2Placebo 2 will be administered post-operatively.	Drug	Group A, Group C
Post-Op acetaminophenAcetaminophen will be administered Post-operatively.	Drug	Group B, Group D, Group E

Primary outcome

Sum Pain Intensity Difference Scores
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)
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
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)
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.

3 secondary outcomes

Number of Participants With Differing Patient Global Evaluation Scores
Time frame: Upto 12.25 hours
Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After 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
Cumulative Number of Participants With Onset of Meaning Pain Relief (MPR) Confirmed at 24 Hours After 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

Results and safety

Results posted to the registry on 23 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A/ Placebo Group	24	22
Group B/ Acetaminophen (APAP) 1000 mg IV Group	23	22
Group C/ Pregabalin (PGB) 300 mg Capsule Group	22	20
Group D/ Combination Co-dosing Group (Post-surgery PGB +APAP)	23	22
Group E/ Combination Split-dosing Group (PGB Pre-surgery + APAP Post-surgery)	23	22

Primary outcome: Sum Pain Intensity Difference Scores

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). Least squares mean (Standard Error). Unit: score on a scale

Measure	Group A/ Placebo Group n = 19	Group B/ APAP Group n = 23	Group C/ PGB Group n = 21	Group D/ Combination Co-dosing Group n = 22	Group E/ Combination Split-dosing Group n = 10
Value	-2.4292 (12.4980)	-68.0778 (11.2879)	-68.3533 (11.8092)	-93.3645 (11.5794)	-82.4099 (17.4418)

Group B/ APAP Group vs Group D/ Combination Co-dosing Group: Least Square (LS) Mean Difference: -25.2868
Group B/ APAP Group vs Group C/ PGB Group: LS Mean Difference: -0.2756
Group A/ Placebo Group vs Group C/ PGB Group: LS Mean Difference: -65.9241

Population analysed: Efficacy Analysis Population included all randomized participants who received study medication post-surgically and did not experience emesis or other major protocol deviations

Primary outcome: Total Pain Relief Measure

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). Least squares mean (Standard Error). Unit: score on a scale

Measure	Group A/ Placebo Group n = 19	Group B/ APAP Group n = 23	Group C/ PGB Group n = 21	Group D/ Combination Co-dosing Group n = 22	Group E/ Combination Split-dosing Group n = 10
Value	17.1038 (15.5619)	88.2775 (14.0551)	94.4433 (14.7042)	121.9596 (14.4180)	91.8373 (21.7176)

Group B/ APAP Group vs Group D/ Combination Co-dosing Group: LS Mean Difference: 33.6821
Group B/ APAP Group vs Group C/ PGB Group: LS Mean Difference: 6.1658
Group A/ Placebo Group vs Group C/ PGB Group: LS Mean Difference: 77.3395

Population analysed: Efficacy Analysis Population: Included all randomized participants who received study medication post-surgically and did not experience emesis or other major protocol deviations

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 15 (± 1 day). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A/ Placebo Group	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24
Group B/ APAP Group	0 of 23 (0%)	3 of 23 (13%)	0 of 23
Group C/ PGB Group	0 of 22 (0%)	14 of 22 (63.6%)	0 of 22
Group D/ Combination Co-dosing Group	0 of 23 (0%)	15 of 23 (65.2%)	0 of 23
Group E/ Combination Split-dosing Group	0 of 23 (0%)	12 of 23 (52.2%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dental Pain

Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain

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.

Kenneth Somberg, MD study director

Nevakar, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pre-Op pregabalin and Post-Op pregabalin in people with Dental Pain, run by Nevakar, Inc. at 1 site 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 3 inclusion and 5 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Sum Pain Intensity Difference Scores (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03652818.

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 23 Nov 2021.