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Completed

NCT Number: NCT01015235

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

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hamilton, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo

Drug

Subcutaneous infusion-once over 4 hours

KAI-1678

Drug

Subcutaneous infusion-once over 4 hours

Other names: Active drug

Ketorolac Tromethamine

Drug

Active comparator, IV infusion, once

Other names: Ketorolac

Primary outcomes

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

    Time frame: Post operative Day 1

Secondary outcomes

  1. The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4)

    Time frame: Post operative Day 1

  2. The effect of KAI-1678 on pain intensity difference (PID) at 4 hours

    Time frame: Post-operative Day 1

  3. The effect of KAI-1678 on total quality analgesia

    Time frame: Post-operative Day 1

  4. The effect of KAI-1678 on time to meaningful pain relief

    Time frame: Post-operative Day 1

Sponsors and collaborators

Lead sponsor

KAI Pharmaceuticals

Industry

Collaborators

  • Trident Clinical Research Pty Ltd

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 18, 2009
Registry last updated
Sep 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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