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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
New Zealand
Study Type
Interventional
Intervention
Ketorolac tromethamine
Ketorolac tromethamine
Placebo
Sponsored by
American Regent, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Waikato Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ketorolac tromethamine (5%)

Ketorolac tromethamine (15%)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours

Secondary Outcome Measures

Total MS Use in Milligrams by PCA From the Start of Dosing Through 48 Hours
Total MS Use in Milligrams by PCA From 24 Hours After the Start of Dosing Through 48 Hours
Pain Intensity Difference (PID) Scores
Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication.

Full Information

First Posted
May 9, 2011
Last Updated
September 14, 2012
Sponsor
American Regent, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01351090
Brief Title
Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine (IN) for Postoperative Pain
Official Title
A Phase 2, Double-blind, Randomized Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
American Regent, Inc.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac tromethamine (5%)
Arm Type
Experimental
Arm Title
Ketorolac tromethamine (15%)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ketorolac tromethamine
Intervention Description
10 mg Intranasal (2 x 100 uL of a 5% solution)
Intervention Type
Drug
Intervention Name(s)
Ketorolac tromethamine
Intervention Description
30 mg Intranasal (2 x 100 uL of a 15% solution)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intranasal
Primary Outcome Measure Information:
Title
Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours
Time Frame
8-hour intervals from the start of dosing through 24 hours
Secondary Outcome Measure Information:
Title
Total MS Use in Milligrams by PCA From the Start of Dosing Through 48 Hours
Time Frame
8-hour intervals from the start of dosing through 48 hours
Title
Total MS Use in Milligrams by PCA From 24 Hours After the Start of Dosing Through 48 Hours
Time Frame
8-hour intervals from 24 hours after the start of dosing through 48 hours
Title
Pain Intensity Difference (PID) Scores
Description
Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication.
Time Frame
6 hours after study drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lincoln Bynum, MD
Organizational Affiliation
ICON Development Solutions
Official's Role
Study Chair
Facility Information:
Facility Name
Waikato Clinical Research
City
Hamilton
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

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