Dental Pain Study of Analgesics in Patients Undergoing Molar Removal

NCT03652818 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CP-NVK009-0001
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Upto 12.25 hours

• Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After Dose 2

  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

  0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours

Study Arms (5)

Group A

EXPERIMENTAL

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

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.

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.

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.

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.

Drug: Pre-Op pregabalin; Drug: Post-Op Placebo 1; Drug: Post-Op acetaminophen

Interventions

Pre-Op pregabalin DRUG

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

Group E

Pre-Op Placebo 1 DRUG

Placebo 1 will be administered 60 min prior to surgery.

Also known as: pre-op placebo

Group A; Group B; Group C; Group D

Post-Op pregabalin DRUG

Post-op pregabalin will be administered Post-operatively.

Group C; Group D

Post-Op Placebo 1 DRUG

Placebo 1 will be administered post-operatively.

Group A; Group B; Group E

Post-Op Placebo 2 DRUG

Placebo 2 will be administered post-operatively.

Group A; Group C

Post-Op acetaminophen DRUG

Acetaminophen will be administered Post-operatively.

Group B; Group D; Group E

Eligibility Criteria

• Age: 17 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Nevakar, Inc.: lead

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Eric Lang, MD
• Organization: Nevakar, Inc.

Clinicaltrials@nevakar.com

(908) 367-7400

Study Officials

• Kenneth Somberg, MD

  Nevakar, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 29, 2018
• Study Start: June 15, 2018
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: November 23, 2021
• Results First Posted: November 23, 2021

Record last verified: 2021-10

Locations

US (1)