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

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ClinicalTrials.gov Identifier: NCT01015235
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : September 2, 2011
Sponsor:
Collaborator:
Trident Clinical Research Pty Ltd
Information provided by (Responsible Party):
KAI Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Pain, Postoperative Drug: Placebo Drug: KAI-1678 Drug: Ketorolac Tromethamine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Arm 1: Placebo
Placebo
Drug: Placebo
Subcutaneous infusion-once over 4 hours
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



Primary Outcome Measures :
  1. The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4). [ Time Frame: Post operative Day 1 ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: KAI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01015235     History of Changes
Other Study ID Numbers: KAI-1678-002
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: August 2011

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
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action