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Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine (IN) for Postoperative Pain

NCT ID: NCT01351090

Last Updated: 2012-10-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2007-10-31

Brief Summary

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This was a randomized, double blind, placebo-controlled study in subjects who have undergone major surgery. Each subject's study participation consisted of a screening visit, a 2-day treatment period, and a follow-up visit. Following surgery, subjects were randomly assigned to receive intranasally (IN) ketorolac 10 mg, IN ketorolac 30 mg, or placebo when the pain intensity (PI) rating equaled at least 40 on a 100-mm visual analog scale (VAS). Thereafter, subjects received study drug every 8 hours, with the last dose given at 40 hours. For pain not relieved by the study drug, the subjects had access to morphine sulfate (MS) administered via patient controlled analgesia (PCA).

The primary objective was to evaluate the analgesic efficacy of multiple intranasal (IN) doses of ketorolac over 2 days. The secondary objective was to evaluate the safety and tolerability of this dosing regimen.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ketorolac tromethamine (5%)

Group Type EXPERIMENTAL

Ketorolac tromethamine

Intervention Type DRUG

10 mg Intranasal (2 x 100 uL of a 5% solution)

Ketorolac tromethamine (15%)

Group Type EXPERIMENTAL

Ketorolac tromethamine

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intranasal

Interventions

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Ketorolac tromethamine

10 mg Intranasal (2 x 100 uL of a 5% solution)

Intervention Type DRUG

Ketorolac tromethamine

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

Intervention Type DRUG

Placebo

Intranasal

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or women, age 18 years or older
* Body weight \> or = 100 pounds (45.4 kg) and \< or = 300 pounds (136.1 kg)
* Women of childbearing potential must have had 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 = 40 mm on a 100-mm VAS
* Expected to remain in the hospital for at least 48 hours
* Willing and able to comply with all testing and requirements defined in the protocol
* Willing and able to complete the posttreatment visit

Exclusion Criteria

* Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)
* Allergic reaction to aspirin or other nonsteroidal anti-inflammatory drug (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
* 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) gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding
* Advanced renal impairment 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
* Allergy or significant reaction to opioids
* Pregnancy or breastfeeding
* Previous participation in this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Regent, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Luitpold Pharmaceuticals, Inc.

Principal Investigators

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Lincoln Bynum, MD

Role: STUDY_CHAIR

ICON Development Solutions

Locations

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Waikato Clinical Research

Hamilton, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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ROX 2001-03

Identifier Type: -

Identifier Source: org_study_id