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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01015235




Registration number
NCT01015235
Ethics application status
Date submitted
16/11/2009
Date registered
18/11/2009
Date last updated
2/09/2011

Titles & IDs
Public title
Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain
Scientific 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
Secondary ID [1] 0 0
KAI-1678-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain, Postoperative 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - KAI-1678
Treatment: Drugs - Ketorolac Tromethamine

Placebo comparator: Arm 1: Placebo - Placebo

Active comparator: A2: KAI-1678 - Test Drug

Active comparator: A3: Ketorolac - Active Comparator


Treatment: Drugs: Placebo
Subcutaneous infusion-once over 4 hours

Treatment: Drugs: KAI-1678
Subcutaneous infusion-once over 4 hours

Treatment: Drugs: Ketorolac Tromethamine
Active comparator, IV infusion, once
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4).
Timepoint [1] 0 0
Post operative Day 1
Secondary outcome [1] 0 0
The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4)
Timepoint [1] 0 0
Post operative Day 1
Secondary outcome [2] 0 0
The effect of KAI-1678 on pain intensity difference (PID) at 4 hours
Timepoint [2] 0 0
Post-operative Day 1
Secondary outcome [3] 0 0
The effect of KAI-1678 on total quality analgesia
Timepoint [3] 0 0
Post-operative Day 1
Secondary outcome [4] 0 0
The effect of KAI-1678 on time to meaningful pain relief
Timepoint [4] 0 0
Post-operative Day 1

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2010
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
KAI Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Trident Clinical Research Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01015235
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory Bell, MD
Address 0 0
KAI Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01015235