A Phase 3 interventional study of experimental anti-anxiety drug in Anxiety Disorder, sponsored by Jazz Pharmaceuticals. Completed at 50 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-10-03.
Sponsored by Jazz Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.
Protocol 04-001-01
The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD).
The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication.
Recruiting: Participants are currently being recruited and enrolled.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 511 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Change in HAM-A Total Score
Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.
Time frame: Baseline to week 8
| Milestone | OROS Alprazolam | IR Alprazolam | Placebo |
|---|---|---|---|
| Started | 173 | 176 | 162 |
| Intent-to-treat (itt) | 165 | 169 | 149 |
| Treated | 171 | 176 | 160 |
| Completed | 109 | 120 | 97 |
| Not completed | 64 | 56 | 65 |
Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.
| Units on a Scale | OROS Alprazolam | IR Alprazolam | Placebo |
|---|---|---|---|
| Change in HAM-A Total Score | -12.9 (-33 to 9) | -15.7 (-36 to 5) | -12.5 (-35 to 4) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OROS Alprazolam | — | 6/171 (3.5%) | 140/171 (81.9%) |
| IR Alprazolam | — | 1/176 (0.6%) | 141/176 (80.1%) |
| Placebo | — | 0/160 (0%) | 118/160 (73.8%) |
| Event | OROS Alprazolam | IR Alprazolam | Placebo |
|---|---|---|---|
| Abdominal Pain UpperGastrointestinal disorders | 1/171 | 0/176 | 0/160 |
| Duodenal Ulcer PerforationGastrointestinal disorders | 1/171 | 0/176 | 0/160 |
| Alcohol PoisoningInjury, poisoning and procedural complications | 1/171 | 0/176 | 0/160 |
| Post Procedural HaemorrhageInjury, poisoning and procedural complications | 1/171 | 0/176 | 0/160 |
| Intentional Self-InjuryPsychiatric disorders | 1/171 | 0/176 | 0/160 |
| Suicide AttemptPsychiatric disorders | 1/171 | 0/176 | 0/160 |
| IleitisGastrointestinal disorders | 0/171 | 1/176 | 0/160 |
| Event | OROS Alprazolam | IR Alprazolam | Placebo |
|---|---|---|---|
| SomnolenceNervous system disorders | 48/171 | 47/176 | 11/160 |
| HeadacheNervous system disorders | 23/171 | 27/176 | 28/160 |
| DizzinessNervous system disorders | 19/171 | 29/176 | 10/160 |
| FatigueGeneral disorders | 25/171 | 23/176 | 14/160 |
| NauseaGastrointestinal disorders | 13/171 | 17/176 | 19/160 |
| Upper Respiratory Tract InfectionInfections and infestations | 17/171 | 20/176 | 9/160 |
| SedationNervous system disorders | 13/171 | 18/176 | 6/160 |
| DiarrhoeaGastrointestinal disorders | 9/171 | 15/176 | 12/160 |
| Dry MouthGastrointestinal disorders | 6/171 | 9/176 | 11/160 |
| InsomniaPsychiatric disorders | 11/171 | 8/176 | 9/160 |
| Age, Continuous(years) | OROS Alprazolam | IR Alprazolam | Placebo | Total |
|---|---|---|---|---|
| Mean | 39.1 ± 12.00 | 38.9 ± 12.02 | 38.5 ± 11.13 | 38.8 ± 11.72 |
| Age, Customized(participants) | OROS Alprazolam | IR Alprazolam | Placebo | Total |
|---|---|---|---|---|
| < 40 years | 87 | 90 | 91 | 268 |
| 40 - < 65 years | 76 | 78 | 58 | 212 |
| >=65 years | 2 | 1 | 0 | 3 |
| Sex: Female, Male(Participants) | OROS Alprazolam | IR Alprazolam | Placebo | Total |
|---|---|---|---|---|
| Female | 95 | 113 | 103 | 311 |
| Male | 70 | 56 | 46 | 172 |
| Region of Enrollment(participants) | OROS Alprazolam | IR Alprazolam | Placebo | Total |
|---|---|---|---|---|
| United States | 165 | 169 | 149 | 483 |
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Jazz Pharmaceuticals