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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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
Other publications