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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014