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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015235
• Other study ID #: KAI-1678-002
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2009
• Last updated: August 31, 2011
• Start date: December 2008
• Est. completion date: February 2010

Study information

• Verified date: August 2011
• Source: KAI Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Medsafe
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Placebo
Subcutaneous infusion-once over 4 hours
• KAI-1678
Subcutaneous infusion-once over 4 hours
• Ketorolac Tromethamine
Active comparator, IV infusion, once

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
KAI Pharmaceuticals	Trident Clinical Research Pty Ltd

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4).		Post operative Day 1	No
Secondary	The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4)		Post operative Day 1	No
Secondary	The effect of KAI-1678 on pain intensity difference (PID) at 4 hours		Post-operative Day 1	No
Secondary	The effect of KAI-1678 on total quality analgesia		Post-operative Day 1	No
Secondary	The effect of KAI-1678 on time to meaningful pain relief		Post-operative Day 1	No