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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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 April 15, 2014