Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01135108