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Completed

NCT Number: NCT00106860

A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder

The purpose of the study is to assess the safety and effectiveness of the experimental drug, a benzodiazepine drug, in long-term use and the effects on quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with anxiety disorder.

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Key information

Conditions

Anxiety Disorder Anxiety Disorders Generalized Anxiety Disorder Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Florida Clinical Research Center, Bradenton, Florida, United States

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About this study

This trial is a long-term, open label, safety and efficacy study of an experimental medication in adults with Generalized Anxiety Disorder (GAD). To enroll in this study, investigators and patients must have first participated in Jazz Pharmaceuticals, Inc. Protocol 04-001-01. The study is designed for four stages that should last a total of 37 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Complete Study 04-001-01
  • Able to take the medication for 9 months
  • Understand and sign the Informed Consent
  • Comply with all study-related procedures
  • Women of child bearing potential must have a confirmed negative urine pregnancy test
  • Lack of clinically significant abnormalities in health

Exclusion criteria

  • Experienced any SAEs (serious adverse events) that were related or possibly related to study drug during participation in Study 04-001-01
  • Early termination from study 04-001-01
  • Any new condition that could interfere with the evaluation of the subject, interpretation of safety data, or compliance with the protocol requirements
  • Experiencing AEs (adverse events) such that in the opinion of the investigator, per protocol, study drug administration or safe participation in this study would be precluded.
  • Taken any disallowed medications noted in Study 04-001-01 between the completion of Study 04-001-01 and entry into this trial

Treatment and study plan

a benzodiazepine drug

Drug

Primary outcomes

  1. Assessment (over 37 additional weeks following the double-blind study) of the safety of the experimental drug in long-term use in subjects with Generalized Anxiety Disorder (GAD)

Secondary outcomes

  1. Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD

  2. Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Registry information

Official study title

A Long-Term, Open Label, Safety and Efficacy Study of an Experimental Medication in Adults With Generalized Anxiety Disorder (GAD)

Important dates

Study start
2005
Study completion
2006
First posted
Apr 1, 2005
Registry last updated
Jan 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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