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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
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
 Drug: Placebo
Drug: KAI-1678
Drug: Ketorolac Tromethamine
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by KAI Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: December 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1: Placebo
Placebo
 Drug: Placebo
Subcutaneous infusion-once over 4 hours
Other Name: Placebo
Active Comparator: A2: KAI-1678
Test Drug
 Drug: KAI-1678
Subcutaneous infusion-once over 4 hours
Other Name: Active drug
Active Comparator: A3: Ketorolac
Active Comparator
 Drug: Ketorolac Tromethamine
Active comparator, IV infusion, once
Other Name: Ketorolac

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015235

Locations
New Zealand
Hamilton, New Zealand
Sponsors and Collaborators
KAI Pharmaceuticals
Trident Clinical Research Pty Ltd
Investigators
Study Director: Gregory Bell, MD KAI Pharmaceuticals
  More Information

No publications provided

Responsible Party: KAI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01015235     History of Changes
Other Study ID Numbers: KAI-1678-002
Study First Received: November 16, 2009
Last Updated: August 31, 2011
Health Authority: New Zealand: Medsafe

Keywords provided by KAI Pharmaceuticals:
Ketorolac / therapeutic use
Analgesics. Non-narcotic / therapeutic use
Arthroplasty, replacement hip
 Arthroplasty, replacement knee
Pain measurement / drug effect
Pain postoperative / drug therapy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ketorolac Tromethamine
Ketorolac
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 13, 2013