Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01135108




Registration number
NCT01135108
Ethics application status
Date submitted
16/04/2010
Date registered
2/06/2010
Date last updated
1/09/2011

Titles & IDs
Public title
Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Spinal Cord Injury
Scientific title
A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Two-Period Crossover Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion in Subjects With Spinal Cord Injury
Secondary ID [1] 0 0
KAI-1678-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

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

Placebo Comparator: A1: Placebo - Placebo

Experimental: A2: KAI-1678 - Experimental


Treatment: Drugs: Placebo
Placebo IV Infusion

Treatment: Drugs: KAI-1678
KAI-1678 IV Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).
Timepoint [1] 0 0
6 hours
Secondary outcome [1] 0 0
The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours
Timepoint [1] 0 0
6 hours
Secondary outcome [2] 0 0
The effect of KAI-1678 on patient global impression of change
Timepoint [2] 0 0
6 hours
Secondary outcome [3] 0 0
The effect of KAI-1678 on symptoms of neuropathic pain assessed by the Neuropathic Pain Scale (NPS)
Timepoint [3] 0 0
6 hours
Secondary outcome [4] 0 0
The number of participants with adverse events as a measure of safety and tolerability of KAI-1678
Timepoint [4] 0 0
Two weeks

Eligibility
Key inclusion criteria
- spinal cord injury at least 1 year prior and nonprogressive ofr at least 6 months

- central neuropathic pain for at least 3 months or with relapses and remissions for at
least 6 months

- pain score at least 4 on 11-point numerical rating scale (0-10)

- stable doses of analgesic medications for at least 1 month
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- history of chronic alcoholism or chronic substance abuse

- tolerance to opioid analgesics

- clinically significant abnormality on laboratory tests or 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
Crossover
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
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

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
pain associated with spinal cord injury.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01135108
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory Bell, MD
Address 0 0
KAI Pharmaceuticals, Inc
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/ct2/show/NCT01135108