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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Anxiety Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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a benzodiazepine drug

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes