Trial | NCT01015235  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ketorolac kai-1678 ...

  • Study Participants

    90
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 Started
Dec 31
2008
Primary Completion
Feb 28
2010
Study Completion
Feb 28
2010
Last Update
Sep 02
2011
Estimate

Drug Placebo

Subcutaneous infusion-once over 4 hours

Drug KAI-1678

Subcutaneous infusion-once over 4 hours

  • Other names: Active drug

Drug Ketorolac Tromethamine

Active comparator, IV infusion, once

  • Other names: Ketorolac

Arm 1: Placebo Placebo Comparator

Placebo

A2: KAI-1678 Active Comparator

Test Drug

A3: Ketorolac Active Comparator

Active Comparator

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)
No Results Posted