Anxiety DisorderPhase 3NCT00106860
A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder
A Phase 3 study testing a benzodiazepine drug in people with Anxiety Disorder, run by Jazz Pharmaceuticals at 13 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder
- What is being tested?
- a benzodiazepine drug
- How many people
- 158 participants
- Where
- 13 sitesUnited States
- Study dates
- Mar 2005to Mar 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Future Search Trials
Austin, Texas, 78756
Northwest Clinical Research Center
Bellevue, Washington, 98004
Florida Clinical Research Center
Bradenton, Florida, 34208
CNS Research Institute (CRI)
Clementon, New Jersey, 08021
Midwest Clinical Research Center
Dayton, Ohio, 45408
Oregon Center for Clinical Research, Inc.
Eugene, Oregon, 97401
Comprehensive Neuroscience of Northern Virginia
Falls Church, Virginia, 22041
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216
Suburban Research Associates
Media, Pennsylvania, 19603
IPS Research Company
Oklahoma City, Oklahoma, 73103
CNS Research Institute (CRI)
Philadelphia, Pennsylvania, 19149
Meridien Research
St. Petersburg, Florida, 33709
Neurology and NeuroscienceCenter of Ohio
Toledo, Ohio, 43623
About this study
Official title: A Long-Term, Open Label, Safety and Efficacy Study of an Experimental Medication in Adults With Generalized Anxiety Disorder (GAD)
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.
Read the detailed description
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
- Anxiety Disorder
- Being tested
- a benzodiazepine drug
- Keywords
- Anxiety, Generalized Anxiety Disorder
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a benzodiazepine drugDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (2)
Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD
Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2005 (estimated)
- Study startMar 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Murray Stein, MD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106860
- Sponsor's protocol ID
- 04-003
- Status last verified
- Jan 2008
- First submitted
- 31 Mar 2005
- Last updated
- 9 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term, Open Label, Safety and Efficacy Study of an Experimental Medication in Adults With Generalized Anxiety Disorder (GAD)
- ClinicalTrials.gov ID
- NCT00106860
- Acronym / sponsor ID
- 04-003
- Conditions
- Anxiety Disorder
- Keywords
- Anxiety, Generalized Anxiety Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Mar 2006
- First posted
- 1 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a benzodiazepine drug | Drug | – |
Primary outcome
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)
2 secondary outcomes
Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD
Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murray Stein, MD study chair
University of California, San Diego
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing a benzodiazepine drug in people with Anxiety Disorder, run by Jazz Pharmaceuticals at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2008.