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

August 31, 2011 updated by: KAI Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm 1: Placebo
Placebo
Drug: Placebo
Subcutaneous infusion-once over 4 hours
Active Comparator: A2: KAI-1678
Test Drug
Drug: KAI-1678
Subcutaneous infusion-once over 4 hours
Other Names:
  • Active drug
Active Comparator: A3: Ketorolac
Active Comparator
Drug: Ketorolac Tromethamine
Active comparator, IV infusion, once
Other Names:
  • Ketorolac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4).
Time Frame: Post operative Day 1
Post operative Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4)
Time Frame: Post operative Day 1
Post operative Day 1
The effect of KAI-1678 on pain intensity difference (PID) at 4 hours
Time Frame: Post-operative Day 1
Post-operative Day 1
The effect of KAI-1678 on total quality analgesia
Time Frame: Post-operative Day 1
Post-operative Day 1
The effect of KAI-1678 on time to meaningful pain relief
Time Frame: Post-operative Day 1
Post-operative Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KAI Pharmaceuticals

Collaborators

Trident Clinical Research Pty Ltd

Investigators

  • Study Director: Gregory Bell, MD, KAI Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Estimate)

September 2, 2011

Last Update Submitted That Met QC Criteria

August 31, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAI-1678-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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