Trial Outcomes & Findings for Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia (NCT NCT00254202)
NCT ID: NCT00254202
Last Updated: 2024-12-13
Results Overview
The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
593 participants
Primary outcome timeframe
4 weeks
Results posted on
2024-12-13
Participant Flow
Participant milestones
| Measure |
Iloperidone
Oral iloperidone
|
Ziprasidone
Oral ziprasidone
|
Placebo
Oral placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
295
|
149
|
149
|
|
Overall Study
Safety Population
|
300
|
150
|
147
|
|
Overall Study
COMPLETED
|
193
|
98
|
90
|
|
Overall Study
NOT COMPLETED
|
102
|
51
|
59
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia
Baseline characteristics by cohort
| Measure |
Iloperidone
n=295 Participants
Oral iloperidone
|
Ziprasidone
n=149 Participants
Oral ziprasidone
|
Placebo
n=149 Participants
Oral placebo
|
Total
n=593 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
40.7 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
245 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
472 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
25 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
147 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
299 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
111 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The modified Intent-to-Treat (ITT) population comprise all randomized patients who receive at least one dose of study medication in the short-term double-blind phase and for whom a baseline PANSS score measurement is obtained and at least one post-baseline PANSS score measurement is obtained while on study medication. For patients randomized in error at a second site after being randomized once, the data from the second site were excluded from analysis in the modified ITT population.
The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Iloperidone
n=283 Participants
Oral iloperidone
|
Ziprasidone
n=144 Participants
Oral ziprasidone
|
Placebo
n=140 Participants
Oral placebo
|
|---|---|---|---|
|
Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score
|
-12.0 score on a scale
Standard Error 1.03
|
-12.3 score on a scale
Standard Error 1.44
|
-7.1 score on a scale
Standard Error 1.48
|
Adverse Events
Iloperidone
Serious events: 2 serious events
Other events: 221 other events
Deaths: 0 deaths
Ziprasidone
Serious events: 2 serious events
Other events: 118 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iloperidone
n=300 participants at risk
Oral iloperidone
|
Ziprasidone
n=150 participants at risk
Oral ziprasidone
|
Placebo
n=147 participants at risk
Oral placebo
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Microcytic anemia
|
0.33%
1/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.00%
0/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.00%
0/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Psychiatric disorders
Psychotic disorder
|
0.33%
1/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
1.3%
2/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.00%
0/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.00%
0/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.68%
1/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
General disorders
Chest pain
|
0.00%
0/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.00%
0/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.68%
1/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.00%
0/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.68%
1/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.00%
0/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.68%
1/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.00%
0/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
1.4%
2/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.00%
0/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.68%
1/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
Other adverse events
| Measure |
Iloperidone
n=300 participants at risk
Oral iloperidone
|
Ziprasidone
n=150 participants at risk
Oral ziprasidone
|
Placebo
n=147 participants at risk
Oral placebo
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
20.3%
61/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
23.3%
35/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
19.7%
29/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
9.7%
29/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
14.0%
21/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
8.8%
13/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Nervous system disorders
Dizziness
|
17.0%
51/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
13.3%
20/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
7.5%
11/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Nervous system disorders
Sedation
|
12.7%
38/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
27.3%
41/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
8.2%
12/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Investigations
Weight increased
|
11.3%
34/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
4.7%
7/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
2.0%
3/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Gastrointestinal disorders
Dry mouth
|
8.7%
26/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
7.3%
11/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.68%
1/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Investigations
Heart rate increased
|
8.0%
24/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
6.0%
9/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.68%
1/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
25/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
3.3%
5/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
2.7%
4/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Cardiac disorders
Tachycardia
|
9.3%
28/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
2.0%
3/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.68%
1/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Nervous system disorders
Extrapyramidal disorder
|
3.3%
10/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
9.3%
14/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
2.0%
3/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Psychiatric disorders
Agitation
|
3.3%
10/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
6.7%
10/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
2.7%
4/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Vascular disorders
Orthostatic hypotension
|
7.0%
21/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.00%
0/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
2.0%
3/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Nervous system disorders
Somnolence
|
4.0%
12/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
6.0%
9/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
1.4%
2/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Psychiatric disorders
Restlessness
|
3.7%
11/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
5.3%
8/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
2.0%
3/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Psychiatric disorders
Anxiety
|
3.0%
9/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
5.3%
8/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.68%
1/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Nervous system disorders
Akathisia
|
1.3%
4/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
7.3%
11/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
0.00%
0/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
24/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
10.0%
15/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
10.2%
15/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Gastrointestinal disorders
Constipation
|
9.0%
27/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
8.0%
12/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
9.5%
14/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
17/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
10.7%
16/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
6.8%
10/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
20/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
8.0%
12/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
6.8%
10/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
General disorders
Fatigue
|
5.3%
16/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
6.0%
9/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
4.8%
7/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Gastrointestinal disorders
Stomach discomfort
|
4.3%
13/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
4.7%
7/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
5.4%
8/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Gastrointestinal disorders
Toothache
|
4.7%
14/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
4.0%
6/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
5.4%
8/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
4/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
4.0%
6/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
5.4%
8/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
|
Psychiatric disorders
Insomnia
|
4.7%
14/300
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
6.7%
10/150
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
6.1%
9/147
The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60