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Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 2
Locations
New Zealand
Study Type
Interventional
Intervention
Placebo
KAI-1678
Ketorolac Tromethamine
Sponsored by
KAI Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Ketorolac / therapeutic use, Analgesics. Non-narcotic / therapeutic use, Arthroplasty, replacement hip, Arthroplasty, replacement knee, Pain measurement / drug effect, Pain postoperative / drug therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologist (ASA) classification 1, 2, or 3
  • total hip or total knee replacement
  • pain on postoperative Day 1 at least 40 mm on 0-100 mm visual analog scale (VAS)

Exclusion Criteria:

  • presence of contraindications to nonsteroidal anti-inflammatory (NSAID) treatment
  • recent history of angina or myocardial infarction (MI)
  • clinically significant abnormality on laboratory tests or electrocardiogram (ECG)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Arm 1: Placebo

A2: KAI-1678

A3: Ketorolac

Arm Description

Placebo

Test Drug

Active Comparator

Outcomes

Primary Outcome Measures

The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4).

Secondary Outcome Measures

The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4)
The effect of KAI-1678 on pain intensity difference (PID) at 4 hours
The effect of KAI-1678 on total quality analgesia
The effect of KAI-1678 on time to meaningful pain relief

Full Information

First Posted
November 16, 2009
Last Updated
August 31, 2011
Sponsor
KAI Pharmaceuticals
Collaborators
Trident Clinical Research Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01015235
Brief Title
Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain
Official Title
A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion for the Treatment of Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KAI Pharmaceuticals
Collaborators
Trident Clinical Research Pty Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Ketorolac / therapeutic use, Analgesics. Non-narcotic / therapeutic use, Arthroplasty, replacement hip, Arthroplasty, replacement knee, Pain measurement / drug effect, Pain postoperative / drug therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
A2: KAI-1678
Arm Type
Active Comparator
Arm Description
Test Drug
Arm Title
A3: Ketorolac
Arm Type
Active Comparator
Arm Description
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous infusion-once over 4 hours
Intervention Type
Drug
Intervention Name(s)
KAI-1678
Other Intervention Name(s)
Active drug
Intervention Description
Subcutaneous infusion-once over 4 hours
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine
Other Intervention Name(s)
Ketorolac
Intervention Description
Active comparator, IV infusion, once
Primary Outcome Measure Information:
Title
The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4).
Time Frame
Post operative Day 1
Secondary Outcome Measure Information:
Title
The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4)
Time Frame
Post operative Day 1
Title
The effect of KAI-1678 on pain intensity difference (PID) at 4 hours
Time Frame
Post-operative Day 1
Title
The effect of KAI-1678 on total quality analgesia
Time Frame
Post-operative Day 1
Title
The effect of KAI-1678 on time to meaningful pain relief
Time Frame
Post-operative Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologist (ASA) classification 1, 2, or 3 total hip or total knee replacement pain on postoperative Day 1 at least 40 mm on 0-100 mm visual analog scale (VAS) Exclusion Criteria: presence of contraindications to nonsteroidal anti-inflammatory (NSAID) treatment recent history of angina or myocardial infarction (MI) clinically significant abnormality on laboratory tests or electrocardiogram (ECG)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Bell, MD
Organizational Affiliation
KAI Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Hamilton
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain

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