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

This study has been completed.
Sponsor:
Collaborator:
Trident Clinical Research Pty Ltd
Information provided by (Responsible Party):
KAI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01015235
First received: November 16, 2009
Last updated: August 31, 2011
Last verified: August 2011
History of Changes

November 16, 2009
August 31, 2011
December 2008
February 2010   (final data collection date for primary outcome measure)
The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4). [ Time Frame: Post operative Day 1 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01015235 on ClinicalTrials.gov Archive Site
  • The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4) [ Time Frame: Post operative Day 1 ] [ Designated as safety issue: No ]
  • The effect of KAI-1678 on pain intensity difference (PID) at 4 hours [ Time Frame: Post-operative Day 1 ] [ Designated as safety issue: No ]
  • The effect of KAI-1678 on total quality analgesia [ Time Frame: Post-operative Day 1 ] [ Designated as safety issue: No ]
  • The effect of KAI-1678 on time to meaningful pain relief [ Time Frame: Post-operative Day 1 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pain, Postoperative
  • Drug: Placebo
    Subcutaneous infusion-once over 4 hours
    Other Name: Placebo
  • Drug: KAI-1678
    Subcutaneous infusion-once over 4 hours
    Other Name: Active drug
  • Drug: Ketorolac Tromethamine
    Active comparator, IV infusion, once
    Other Name: Ketorolac
  • Placebo Comparator: Arm 1: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: A2: KAI-1678
    Test Drug
    Intervention: Drug: KAI-1678
  • Active Comparator: A3: Ketorolac
    Active Comparator
    Intervention: Drug: Ketorolac Tromethamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
February 2010
February 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT01015235
KAI-1678-002
Yes
KAI Pharmaceuticals
KAI Pharmaceuticals
Trident Clinical Research Pty Ltd
Study Director: Gregory Bell, MD KAI Pharmaceuticals
KAI Pharmaceuticals
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP