Trial Outcomes & Findings for Experimental Medication For the Treatment of Generalized Anxiety Disorder (NCT NCT00097708)
NCT ID: NCT00097708
Last Updated: 2014-10-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
511 participants
Primary outcome timeframe
Baseline to week 8
Results posted on
2014-10-03
Participant Flow
Participant milestones
| Measure |
OROS Alprazolam
OROS (osmotic \[controlled\] release oral \[delivery\] system) alprazolam administered orally once a day, titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
|
IR Alprazolam
IR (immediate release) alprazolam (Xanax) administered orally in divided dose (3 times daily), titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
|
Placebo
OROS (osmotic \[controlled\] release oral \[delivery\] system) placebo administered orally once a day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
173
|
176
|
162
|
|
Overall Study
Intent-to-Treat (ITT)
|
165
|
169
|
149
|
|
Overall Study
Treated
|
171
|
176
|
160
|
|
Overall Study
COMPLETED
|
109
|
120
|
97
|
|
Overall Study
NOT COMPLETED
|
64
|
56
|
65
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Experimental Medication For the Treatment of Generalized Anxiety Disorder
Baseline characteristics by cohort
| Measure |
OROS Alprazolam
n=165 Participants
|
IR Alprazolam
n=169 Participants
|
Placebo
n=149 Participants
|
Total
n=483 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 12.00 • n=5 Participants
|
38.9 years
STANDARD_DEVIATION 12.02 • n=7 Participants
|
38.5 years
STANDARD_DEVIATION 11.13 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 11.72 • n=4 Participants
|
|
Age, Customized
< 40 years
|
87 participants
n=5 Participants
|
90 participants
n=7 Participants
|
91 participants
n=5 Participants
|
268 participants
n=4 Participants
|
|
Age, Customized
40 - < 65 years
|
76 participants
n=5 Participants
|
78 participants
n=7 Participants
|
58 participants
n=5 Participants
|
212 participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
311 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
172 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
165 participants
n=5 Participants
|
169 participants
n=7 Participants
|
149 participants
n=5 Participants
|
483 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 8Hamilton 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.
Outcome measures
| Measure |
OROS Alprazolam
n=162 Participants
|
IR Alprazolam
n=159 Participants
|
Placebo
n=145 Participants
|
|---|---|---|---|
|
Change in HAM-A Total Score
|
-12.9 Units on a Scale
Interval -33.0 to 9.0
|
-15.7 Units on a Scale
Interval -36.0 to 5.0
|
-12.5 Units on a Scale
Interval -35.0 to 4.0
|
Adverse Events
OROS Alprazolam
Serious events: 6 serious events
Other events: 140 other events
Deaths: 0 deaths
IR Alprazolam
Serious events: 1 serious events
Other events: 141 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OROS Alprazolam
n=171 participants at risk
|
IR Alprazolam
n=176 participants at risk
|
Placebo
n=160 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.58%
1/171
|
0.00%
0/176
|
0.00%
0/160
|
|
Gastrointestinal disorders
Duodenal Ulcer Perforation
|
0.58%
1/171
|
0.00%
0/176
|
0.00%
0/160
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/171
|
0.57%
1/176
|
0.00%
0/160
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.58%
1/171
|
0.00%
0/176
|
0.00%
0/160
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.58%
1/171
|
0.00%
0/176
|
0.00%
0/160
|
|
Psychiatric disorders
Intentional Self-Injury
|
0.58%
1/171
|
0.00%
0/176
|
0.00%
0/160
|
|
Psychiatric disorders
Suicide Attempt
|
0.58%
1/171
|
0.00%
0/176
|
0.00%
0/160
|
Other adverse events
| Measure |
OROS Alprazolam
n=171 participants at risk
|
IR Alprazolam
n=176 participants at risk
|
Placebo
n=160 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.6%
13/171
|
9.7%
17/176
|
11.9%
19/160
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
9/171
|
8.5%
15/176
|
7.5%
12/160
|
|
Gastrointestinal disorders
Dry Mouth
|
3.5%
6/171
|
5.1%
9/176
|
6.9%
11/160
|
|
General disorders
Fatigue
|
14.6%
25/171
|
13.1%
23/176
|
8.8%
14/160
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.9%
17/171
|
11.4%
20/176
|
5.6%
9/160
|
|
Nervous system disorders
Somnolence
|
28.1%
48/171
|
26.7%
47/176
|
6.9%
11/160
|
|
Nervous system disorders
Headache
|
13.5%
23/171
|
15.3%
27/176
|
17.5%
28/160
|
|
Nervous system disorders
Dizziness
|
11.1%
19/171
|
16.5%
29/176
|
6.2%
10/160
|
|
Nervous system disorders
Sedation
|
7.6%
13/171
|
10.2%
18/176
|
3.8%
6/160
|
|
Psychiatric disorders
Insomnia
|
6.4%
11/171
|
4.5%
8/176
|
5.6%
9/160
|
Additional Information
Grace Wang, MD Director Clinical Development & Medical Monitor
Jazz Pharmaceuticals, Inc.
Phone: 650 - 496 - 3777
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER