A Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery

NCT ID: NCT01356225

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29

Brief Summary

The purpose of this study is to evaluate the analgesic efficacy of a single intranasal (IN) administration of ketorolac after dental impaction surgery.

Conditions

Pain; Dental Impaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intranasal Ketorolac tromethamine

Group Type: EXPERIMENTAL

Ketorolac tromethamine

Intervention Type: DRUG

30 mg Intranasal (2 x 100 uL of a 15% solution), single dose

Intranasal placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IN placebo

Interventions

Ketorolac tromethamine

30 mg Intranasal (2 x 100 uL of a 15% solution), single dose

Intervention Type: DRUG

Placebo

IN placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men or women, age 18 years or older.
• Body weight > or = to 100 pounds and < or = 300 pounds.
• Women of childbearing potential must have a negative serum pregnancy test result prior to entry into the study.
• Able to provide written informed consent.
• At least moderate pain as determined by a PI score of > or = to 50 mm on a 100-mm VAS.
• Willing and able to comply with all testing and requirements defined in the protocol.
• Willing and able to complete the posttreatment visit.
• Immediately prior to entering the study, surgical removal of 3 or 4 third molars (at least 1 mandibular partial bony or complete bony impaction).

Exclusion Criteria

• Allergy or sensitivity to ketorolac or EDTA.
• Allergic reaction to aspirin or other NSAIDs.
• Current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of adverse events (AEs).
• Use of any IN product within 24 hours prior to study entry.
• Clinically significant abnormality on screening laboratory tests.
• History of cocaine use resulting in nasal mucosal damage.
• Active peptic ulcer disease, recent (defined as within 6 months) history of peptic ulcer disease or gastrointestinal bleeding considered by the investigator to be clinically significant.
• Advanced renal impairment (serum creatinine >1.5 mg/dL) or a risk for renal failure due to volume depletion.
• A history of any other clinically significant medical problem, which in the opinion of the investigator would interfere with study participation.
• Participation within 30 days of study entry or within 5 times the half- life, whichever is longer, in another investigational drug study.
• Pregnancy or breastfeeding.
• Extraction of teeth other than third molars during the surgical procedure; exceptions:(1) supernumerary third molars; (2) cases whereby extraction of a third molar requires the removal of an adjacent molar.
• Previous participation in this study.
• Use of any short-acting NSAID (such as aspirin or ibuprofen) or acetaminophen within 12 hours of surgery.
• Use of longer-acting NSAIDs (such as naproxen sodium) within 48 hours of surgery or piroxicam within 7 days of surgery.
• Use of steroids (other than oral contraceptives) within 72 hours of surgery.
• Use of mood-altering drugs, such a cannabis or alcohol, within 12 hours of surgery.
• Surgical anesthesia including narcotic agents except fentanyl. Short-acting anesthetics, both DEA scheduled and unscheduled, were allowed. Naloxone in any form was not permitted.
• Use of any other medication within 24 hours prior to surgery that, in the opinion of the investigator, could confound the subject's efficacy assessments (eg, sedatives, tranquilizers, MAO inhibitors, phenothiazines).
• Consumption of any caffeine-containing products within 4 hours of surgery.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egalet Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Luitpold Pharmaceuticals

Principal Investigators

Lincoln Bynum, MD

Role: STUDY_CHAIR

GloboMax (ICON plc)

Locations

Austin Oral Surgery - PPD Development

Austin, Texas, United States

Countries

United States

Other Identifiers

ROX 2003-05

Identifier Type: -

Identifier Source: org_study_id