Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00141375




Registration number
NCT00141375
Ethics application status
Date submitted
30/08/2005
Date registered
1/09/2005
Date last updated
15/01/2008

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
Sex
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
1/08/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2006
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/ct2/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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00141375