Phase 2
N=115
Dental Pain Study of Analgesics in Patients Undergoing Molar Removal
Dental Pain
Bottom Line
View on ClinicalTrials.gov: NCT03652818 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Sum Pain Intensity Difference Scores — -2.4292; -68.0778; -68.3533; -93.3645 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 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 (Drug)
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- All
- Sponsor
- Nevakar, Inc.
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum Pain Intensity Difference Scores |
-2.4292; -68.0778; -68.3533; -93.3645; -82.4099 | — |
| PRIMARY Total Pain Relief Measure |
17.1038; 88.2775; 94.4433; 121.9596; 91.8373 | — |
| SECONDARY Number of Participants With Differing Patient Global Evaluation Scores |
13; 1; 8; 0; 0; 3 | — |
| SECONDARY Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After Dose 2 |
12; 23; 17; 22; 10 | — |
| SECONDARY Cumulative Number of Participants With Onset of Meaning Pain Relief (MPR) Confirmed at 24 Hours After Dose 2 |
3; 20; 11; 17; 10 | — |
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.
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.)
Data sourced from ClinicalTrials.gov (NCT03652818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.