Back to resultsSafety and Efficacy of AGN201781 in Neuropathic Pain
Primary Purpose
Neuralgia
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AGN201781
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Neuralgia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of postherpetic neuralgia or post-traumatic peripheral neuralgia
- Moderate or severe pain associated with postherpetic neuralgia or post-traumatic peripheral neuralgia
Exclusion Criteria:
- Women of child-bearing potential
- Any other uncontrolled diseases
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AGN201781
Placebo
Arm Description
AGN201781 50 mg capsules three-time daily for 2 weeks
placebo 50 mg capsules three-times daily for 2 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00533351
Brief Title
Safety and Efficacy of AGN201781 in Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early due to low enrollment.
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGN201781
Arm Type
Experimental
Arm Description
AGN201781 50 mg capsules three-time daily for 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo 50 mg capsules three-times daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
AGN201781
Intervention Description
AGN201781 50 mg capsules three-times daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo 50 mg capsules three-times daily for 2 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Daily Pain Score at Week 2
Description
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
Time Frame
Baseline, Week 2
Secondary Outcome Measure Information:
Title
Change From Baseline in Subject Global Impression of Change Score at Week 2
Description
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.
Time Frame
Baseline, Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of postherpetic neuralgia or post-traumatic peripheral neuralgia
Moderate or severe pain associated with postherpetic neuralgia or post-traumatic peripheral neuralgia
Exclusion Criteria:
Women of child-bearing potential
Any other uncontrolled diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
St. Leonards
State/Province
New South Wales
Country
Australia
City
Kiel
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of AGN201781 in Neuropathic Pain
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