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.
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.
Group
Value
95% CI
Group A/ Placebo Group
17.1038
± 15.5619
Group B/ APAP Group
88.2775
± 14.0551
Group C/ PGB Group
94.4433
± 14.7042
Group D/ Combination Co-dosing Group
121.9596
± 14.4180
Group E/ Combination Split-dosing Group
91.8373
± 21.7176
Number of Participants With Differing Patient Global Evaluation ScoresSecondary· Upto 12.25 hours
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.
(0) Poor
Group
Value
95% CI
Group A/ Placebo Group
13
Group B/ APAP Group
1
Group C/ PGB Group
8
Group D/ Combination Co-dosing Group
0
Group E/ Combination Split-dosing Group
0
(1) Fair
Group
Value
95% CI
Group A/ Placebo Group
3
Group B/ APAP Group
2
Group C/ PGB Group
2
Group D/ Combination Co-dosing Group
3
Group E/ Combination Split-dosing Group
1
(2) Good
Group
Value
95% CI
Group A/ Placebo Group
1
Group B/ APAP Group
7
Group C/ PGB Group
4
Group D/ Combination Co-dosing Group
4
Group E/ Combination Split-dosing Group
1
(3) Very good
Group
Value
95% CI
Group A/ Placebo Group
2
Group B/ APAP Group
8
Group C/ PGB Group
6
Group D/ Combination Co-dosing Group
10
Group E/ Combination Split-dosing Group
6
(4) Excellent
Group
Value
95% CI
Group A/ Placebo Group
0
Group B/ APAP Group
5
Group C/ PGB Group
1
Group D/ Combination Co-dosing Group
5
Group E/ Combination Split-dosing Group
2
Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After Dose 2Secondary· 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours
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.
Group
Value
95% CI
Group A/ Placebo Group
12
Group B/ APAP Group
23
Group C/ PGB Group
17
Group D/ Combination Co-dosing Group
22
Group E/ Combination Split-dosing Group
10
Cumulative Number of Participants With Onset of Meaning Pain Relief (MPR) Confirmed at 24 Hours After Dose 2Secondary· 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours
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.
Group
Value
95% CI
Group A/ Placebo Group
3
Group B/ APAP Group
20
Group C/ PGB Group
11
Group D/ Combination Co-dosing Group
17
Group E/ Combination Split-dosing Group
10
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Day 15 (± 1 day).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
* 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT07239505 — A Randomized Controlled Trial Evaluating Whether Pre-operative Trinase Reduces Post-operative Pain in Patients With Symp
· NA
· recruiting
NCT06948162 — Exploration of the Utility of Dental-dedicated MRI for Dentistry
· recruiting
NCT05351099 — Dental Block for Pain Relief in ED Dental Pain Patients
· recruiting
Other Nevakar, Inc. trials
Trials by the same sponsor.
NCT04495283 — A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bu
· Phase 2
· completed
NCT04265456 — A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers
· Phase 1
· completed
NCT04018612 — A Study of Acetaminophen for Post Surgical Dental Pain
· Phase 2
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Nevakar, Inc.
Last refreshed: 23 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03652818.