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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00533351
Registration number
NCT00533351
Ethics application status
Date submitted
19/09/2007
Date registered
21/09/2007
Date last updated
24/02/2016
Titles & IDs
Public title
Safety and Efficacy of AGN201781 in Neuropathic Pain
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Scientific title
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Secondary ID [1]
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201781-504
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neuralgia
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AGN201781
Treatment: Drugs - placebo
Experimental: AGN201781 - AGN201781 50 mg capsules three-time daily for 2 weeks
Placebo comparator: Placebo - placebo 50 mg capsules three-times daily for 2 weeks
Treatment: Drugs: AGN201781
AGN201781 50 mg capsules three-times daily for 2 weeks
Treatment: Drugs: placebo
placebo 50 mg capsules three-times daily for 2 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Daily Pain Score at Week 2
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Assessment method [1]
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Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed
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Timepoint [1]
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Baseline, Week 2
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Secondary outcome [1]
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Change From Baseline in Subject Global Impression of Change Score at Week 2
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Assessment method [1]
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Change from baseline in Subject Global Impression of Change score at week 2. The Subject Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale (1=very much improved to 7=very much worse). Due to low number of patients completing the treatment period of the study no analyses were performed.
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Timepoint [1]
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Baseline, Week 2
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Eligibility
Key inclusion criteria
* Diagnosis of postherpetic neuralgia or post-traumatic peripheral neuralgia
* Moderate or severe pain associated with postherpetic neuralgia or post-traumatic peripheral neuralgia
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Women of child-bearing potential
* Any other uncontrolled diseases
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2008
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Sample size
Target
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Accrual to date
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Final
9
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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- St. Leonards
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Recruitment postcode(s) [1]
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- St. Leonards
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Kiel
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia
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Trial website
https://clinicaltrials.gov/study/NCT00533351
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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 are available at
https://clinicaltrials.gov/study/NCT00533351
Download to PDF