Safety and Efficacy of AGN201781 in Neuropathic Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

September 19, 2007

Last Updated Date

October 22, 2008

Start Date ^ICMJE

March 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Daily Average Pain Score [ Time Frame: Day 1 - Week 8 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Reduction in daily pain scores

Change History

Complete list of historical versions of study NCT00533351 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Use of supplemental analgesia [ Time Frame: Day 1 - Week 8 ] [ Designated as safety issue: No ]
Daily sleep interference [ Time Frame: Day 1 - Week 8 ] [ Designated as safety issue: No ]
Quantitative Sensory Testing [ Time Frame: Day 1 - Week 8 ] [ Designated as safety issue: No ]
Quality of Life questionnaires [ Time Frame: Day 1 - Week 8 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of AGN201781 in Neuropathic Pain

Official Title ^ICMJE

Brief Summary

This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Neuralgia

Intervention ^ICMJE

Drug: AGN 201781
Drug: placebo capsule

Study Arms / Comparison Groups

Experimental: 50 mg
Placebo Comparator: Placebo capsule

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Germany

Administrative Information

NCT ID ^ICMJE

NCT00533351

Responsible Party

Therapeutic Area Head, Allergan, Inc.

Study ID Numbers ^ICMJE

201781-504

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP