Safety and Efficacy of AGN201781 in Neuropathic Pain - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00533351

Purpose

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

Condition	Intervention	Phase
Neuralgia	Drug: AGN 201781 Drug: placebo capsule	Phase II

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

Further study details as provided by Allergan:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	9
Study Start Date:	March 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 50 mg	Drug: AGN 201781 50 mg capsules three-times daily for 2 weeks
2: Placebo Comparator Placebo capsule	Drug: placebo capsule 50 mg capsules three-times daily for 2 weeks

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533351

Locations

Australia, New South Wales

St. Leonards, New South Wales, Australia
Germany

Kiel, Germany

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	201781-504
Study First Received:	September 19, 2007
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00533351
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Australia: Therapeutic Goods Agency

Study placed in the following topic categories:

Signs and Symptoms
Neuromuscular Diseases
Neuralgia

Peripheral Nervous System Diseases
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009