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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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
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 - 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.
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
Gender
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
Terminated
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
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/show/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/show/NCT00533351