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Safety and Efficacy of AGN201781 in Neuropathic Pain

This study has been terminated.
(This study was terminated early due to low enrollment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00533351
First Posted: September 21, 2007
Last Update Posted: February 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00533351     History of Changes
Other Study ID Numbers: 201781-504
First Submitted: September 19, 2007
First Posted: September 21, 2007
Results First Submitted: December 15, 2011
Results First Posted: January 19, 2012
Last Update Posted: February 24, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms