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/show/NCT00141375




Trial ID
NCT00141375
Ethics application status
Date submitted
30/08/2005
Date registered
31/08/2005
Date last updated
9/01/2008

Titles & IDs
Public title
To Evaluate Long-Term Safety and Efficacy of Pregabalin in the Treatment of Neuropathic Pain After Spinal Cord Injury.
Scientific title
An Open-Label Extension to Evaluate the Safety and Efficacy of Pregabalin for Treatment of Chronic Central Neuropathic Pain After Spinal Cord Injury.
Secondary ID [1] 0 0
1008-000-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuropathic Pain 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

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

Treatment: Drugs: Pregabalin


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Efficacy
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Must have met the inclusion criteria of the preceding double-blind BID study in
central pain following spinal cord injury.

- Must have received study medication under double-blind conditions.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients cannot participate if they experienced a serious adverse event during the
previous double-blind BID study which was determined to be related to the study
medication.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
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)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Little Bay
Recruitment hospital [2] 0 0
Pfizer Investigational Site - St. Leonards
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Warrawong
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Woolloongabba
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Heidelberg
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Shenton Park
Recruitment hospital [7] 0 0
Pfizer Investigational Site - NSW
Recruitment postcode(s) [1] 0 0
2036 - Little Bay
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
2502 - Warrawong
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
6008 - Shenton Park
Recruitment postcode(s) [7] 0 0
- NSW

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate long-term safety and efficacy of pregabalin in the treatment of neuropathic pain
after spinal cord injury.
Trial website
https://clinicaltrials.gov/show/NCT00141375
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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