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/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
Scientific title
Secondary ID [1] 0 0
201781-504
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuralgia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Daily Pain Score at Week 2
Timepoint [1] 0 0
Baseline, Week 2
Secondary outcome [1] 0 0
Change From Baseline in Subject Global Impression of Change Score at Week 2
Timepoint [1] 0 0
Baseline, Week 2

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women of child-bearing potential
* Any other uncontrolled diseases

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 assessing the outcomes
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- St. Leonards
Recruitment postcode(s) [1] 0 0
- St. Leonards
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Kiel

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia
Trial website
https://clinicaltrials.gov/study/NCT00533351
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
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/study/NCT00533351