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
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, see Learn About Clinical Studies.

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 July 22, 2014