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History of Changes for Study: NCT02356965
Study Testing a Pain Medication After Wisdom Tooth Extraction
Latest version (submitted March 24, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 5, 2015 None (earliest Version on record)
2 March 13, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 March 24, 2015 Study Status and Study Identification
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Study NCT02356965
Submitted Date:  February 5, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: KET005
Brief Title: Study Testing a Pain Medication After Wisdom Tooth Extraction
Official Title: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Dose Ranging Study to Assess the Analgesic Efficacy, Tolerability, Safety and Pharmacokinetic/Pharmacodynamic Properties of A Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2015
Overall Status: Recruiting
Study Start: December 2014
Primary Completion: February 2015 [Anticipated]
Study Completion: February 2015 [Anticipated]
First Submitted: January 29, 2015
First Submitted that
Met QC Criteria:
February 5, 2015
First Posted: February 6, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 5, 2015
Last Update Posted: February 6, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: iX Biopharma Ltd.
Responsible Party: Sponsor
Collaborators: Jean Brown Research
Lotus Clinical Research, LLC
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of the study is to test two different doses of ketamine sub-lingual (under the tongue) wafer against placebo to see how effective the medication is to treat moderate to severe pain after wisdom tooth extraction.
Detailed Description:

This is a Phase 2, randomized, double-blind, parallel group, dose-ranging placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of ketamine sublingual wafer in adult subjects who experience post-operative pain after undergoing third molar extraction.

The study will enroll approximately 80 subjects at a single site. Subjects will be at least 18 years to 38 years of age. Subjects will receive a single dose of 70 mg or 100 mg sublingual ketamine wafer or placebo.

Efficacy assessment will include pain intensity, use of rescue medication, and Patient Global Assessment (PGA) of pain control. Safety assessments will include monitoring of AEs and SAEs, clinical laboratory tests, vital sign measurements, oral assessments, and ECGs.

A maximum of eight 4ml blood samples will be taken from each participant up to 8 hours after study drug administration for plasma analysis.

Open or close this module Conditions
Conditions: Pain
Keywords: Third molar extraction
Wisdom tooth extraction
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 80 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Ketamine 70 mg Sublingual Wafer
Single dose of 70 mg ketamine sublingual wafer
Drug: Ketamine
Single dose of sublingual investigational medication administered when subjects develop moderate to severe pain after third molar extraction.
Experimental: Ketamine 100 mg Sublingual Wafer
Single dose of 100 mg ketamine sublingual wafer
Drug: Ketamine
Single dose of sublingual investigational medication administered when subjects develop moderate to severe pain after third molar extraction.
Placebo Comparator: Placebo
Single dose of placebo sublingual wafer
Drug: Placebo (for Ketamine)
Sublingual sugar pill developed to mimic ketamine sublingual dose.
Other Names:
  • Sugar pill
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Sum of Pain Intensity Difference
[ Time Frame: 3 hours ]

Demonstrate the dose-response relationship for analgesia of two dose levels of ketamine sublingual wafer compared with placebo, using the summed pain intensity difference from baseline over the first 3 hours (SPID3) in subjects with acute moderate to severe pain following third molar extraction.
Secondary Outcome Measures:
1. Sum of Pain Intensity Difference
[ Time Frame: 6 hours ]

Summed Pain Intensity Difference at 6 hours (SPID 6).
2. Safety and Tolerability evaluated by physical examination, vital signs, pulse oximetry, clinical laboratory tests, ECGs and Incident of Adverse Events (AEs) and Serious Adverse Events (SAEs).
[ Time Frame: 8 hours ]

Safety and tolerability of ketamine sublingual wafer as evaluated by physical examination, vital signs, pulse oximetry, clinical laboratory tests, ECGs and Incident of Adverse Events (AEs) and Serious Adverse Events (SAEs).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 38 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria: Healthy male and female subjects, ages 18-38 years old, who are scheduled to undergo two ipsilateral third molar extractions.
Open or close this module Contacts/Locations
Central Contact Person: Georgia Simmons, BSN
Telephone: +1-801-694-7846
Email: georgia.simmons@ixbiopharma.com
Central Contact Backup: Paul Rolan, MD
Telephone: +61 4 0567 0420
Email: paul.rolan@ixbiopharma.com
Study Officials: Derek D Muse, MD
Principal Investigator
Jean Brown Research
Locations: United States, Utah
Jean Brown Research
[Recruiting]
Salt Lake City, Utah, United States, 84124
Contact:Contact: Jenny Hunt 801-261-2000 jhunt@jbrutah.com
Contact:Principal Investigator: Derek D Muse, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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