Safety and Efficacy of AGN201781 in Neuropathic Pain

This study has been terminated.

(This study was terminated early due to low enrollment.)

Sponsor:

Information provided by (Responsible Party):

Allergan

ClinicalTrials.gov Identifier:

NCT00533351

First received: September 19, 2007

Last updated: December 15, 2011

Last verified: December 2011

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: AGN201781 Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Further study details as provided by Allergan:

Primary Outcome Measures:

Change From Baseline in Daily Pain Score at Week 2 [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
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.

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
Experimental: AGN201781 AGN201781 50 mg capsules three-time daily for 2 weeks	Drug: AGN201781 AGN201781 50 mg capsules three-times daily for 2 weeks
Placebo Comparator: Placebo placebo 50 mg capsules three-times daily for 2 weeks	Drug: placebo placebo 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

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00533351 History of Changes
Other Study ID Numbers:	201781-504
Study First Received:	September 19, 2007
Results First Received:	December 15, 2011
Last Updated:	December 15, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Australia: Therapeutic Goods Agency

Additional relevant MeSH terms:

Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases

Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013