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

NCT01015235 — Phase 2, Completed, 90 participants, KAI Pharmaceuticals

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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

Registry	NCT01015235
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	90 (Actual)
Sponsor	KAI Pharmaceuticals (Industry); collaborators: Trident Clinical Research Pty Ltd
Conditions	Pain, Postoperative
Interventions	Placebo, KAI-1678, Ketorolac Tromethamine (Drug)
Dates	start 2008-12-01, primary completion 2010-02-01, completion 2010-02-01, first posted 2009-11-18, last updated 2011-09-02
Locations	1 site in New Zealand

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Arm 1: Placebo	Placebo comparator	Drug: Placebo	Placebo
A2: KAI-1678	Active comparator	Drug: KAI-1678	Test Drug
A3: Ketorolac	Active comparator	Drug: Ketorolac Tromethamine	Active Comparator

Placebo (Drug): Subcutaneous infusion-once over 4 hours
KAI-1678 (Drug), also known as Active drug: Subcutaneous infusion-once over 4 hours
Ketorolac Tromethamine (Drug), also known as Ketorolac: Active comparator, IV infusion, once

+Outcome measures

Primary outcomes

The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4). [Post operative Day 1]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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)

+Locations (1)

Facility	City	Country	Status
	Hamilton	New Zealand

+Investigators

Gregory Bell, MD, Study director, KAI Pharmaceuticals