eXtRa: Compare the Effect on Cognitive Functioning of Two Formulations of Seroquel, Seroquel XR and IR in Patients With Stable Schizophrenia
Study Details
Study Description
Brief Summary
This will be a phase IV 20 -32 day prospective, double blind, double-dummy, randomised crossover study that will evaluate the effect of quetiapine XR and quetiapine IR on cognitive performance in patients with schizophrenia stabilized on a single antipsychotic medication.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: First Seroquel XR then Seroquel IR Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days |
Drug: Seroquel XR- quetiapine fumarate extended release
Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days.
Drug: Seroquel IR - quetiapine fumarate
Seroquel IR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken twice a day for 10-16 days.
Drug: Placebo matching Seroquel XR
Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days.
Drug: Placebo matching Seroquel IR
Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.
|
| Active Comparator: First Seroquel IR then Seroquel XR Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days |
Drug: Seroquel XR- quetiapine fumarate extended release
Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days.
Drug: Seroquel IR - quetiapine fumarate
Seroquel IR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken twice a day for 10-16 days.
Drug: Placebo matching Seroquel XR
Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days.
Drug: Placebo matching Seroquel IR
Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.
|
Outcome Measures
Primary Outcome Measures
- Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance) [Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.]
Attentional standardised composite score: Standardised speed of performance score. Higher Score=better performance. Score range minus infinity to plus infinity. Measured at baseline (before study drug administration) and in Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. (Last test day not earlier than after 10 days of randomised)and in Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Last test day not earlier than after 10 days of crossover treatment.
Secondary Outcome Measures
- Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) [Before taking study drug, end of Period 1 and end of Period 2]
TSQM is a 14-item questionnaire with 4 sub-scales: effectiveness of the medication; treatment side effects; convenience of the medication; global satisfaction with the medication. Scale range 0-100 for each sub-scale, higher=greater satisfaction/milder side effects/greater convenience/greater overall satisfaction. There are 2 measurement, (after the start of taking study drug) one at end of period 1 and one at end of period 2. That is one measurement per patient per treatment. The mean of all the patients is presented, one mean value per treatment group.
- Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving [Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.]
International Shopping List Task (ISLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, higher score=better performance. Groton Maze Learning Test (GMLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, lower score=better performance. Lower=better performance. One Back memory task (ONB: measures working memory, min=minus infinity, max=plus infinity, lower score=better performance.
- Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label [Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.]
The modified Bond-Lader VAS: The degree of sedation was marked by the patient on a 100 mm VAS ranging between Alert (=0 mm) and Drowsy (=100 mm). The marked length in millimetres. There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group.
- Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label [Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.]
Stanford Sleepiness Scale: The sleepiness was assessed by the patient on a 7 item rating scale ranging from 1 (Feeling active and vital) to 7 (Almost in reverie). There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group.
- Number of Dropouts. [Period 1 and Period 2]
The number of patients who dropped out was counted.
- Mean Ratio of Morning Plasma Concentration of Quetiapine and Nor-quetiapine for Quetiapine IR and Quetiapine XR, at Steady-state Conditions in the End of Each Treatment Period 1 and 2. [End of Period 1, end of Period 2]
The ratio was derived as individual plasma concentration of quetiapine divided by the plasma concentration of nor-quetiapine. The mean ratio was derived for each treatment, XR and IR, respectively.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Provision of written informed consent prior to any study specific procedures
-
Documented clinical diagnosis of schizophrenia, paranoid type, for at least 2 years before randomisation meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV, American Psychiatric Association 2000) criteria of schizophrenia (DSM-IV codes 295.3) confirmed by MINI version 5.0
-
Outpatient status at enrolment
-
Dose of quetiapine IR or quetiapine XR unchanged during the last 56 days before randomisation
Exclusion Criteria:
-
Diagnosis of any DSM-IV Axis I disorder other than those included in inclusion criteria above within 6 months before randomisation (e.g., alcohol dependence or psychoactive substance dependence not in full remission, concurrent organic mental disorder, or mental retardation [axis II diagnosis]) of a degree that may interfere with the patient's ability to co-operate.
-
Previous stable use of high dosage of benzodiazepines during one year or more
-
Significant neurological medical history (complicated head trauma as judged by the investigator, epilepsy, meningo-encephalitis)
-
Use of the following medication:
-
other antipsychotic drug than quetiapine within 28 days prior to randomisation
-
a depot antipsychotic injection within two dosing intervals (for the depot) before randomisation (Visit 2)
-
other psychoactive drugs within 14 days prior to randomisation (hypnotic or anxiolytic drugs, other than those allowed)
-
Use of concomitant therapy likely to affect cognition, Medication prohibited 28 days prior to randomisation: benzodiazepines, amphetamines, reboxitin, atomoxinetine, buspiron, donepezil, duloxetine, galantamine, ginko biloba, memantine, methylphenidate, modafinil, rivastigmine, tacrine, smoking cessation therapy varencicline and any dosage form of nicotine replacement therapy. Medication prohibited 14 days prior to randomisation: irreversible monoamine oxidase inhibitors (MAOI), tricyclic antidepressants (TCA), biperiden, antoicholinergic agents (even if the indications are extra pyramidal symptoms or urinary symptoms)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Wien | Austria | ||
| 2 | Research Site | Middelfart | Denmark | ||
| 3 | Research Site | Berlin | Germany | ||
| 4 | Research Site | Bochum | Germany | ||
| 5 | Research Site | Hamburg | Germany | ||
| 6 | Research Site | Munchen | Germany | ||
| 7 | Research Site | Rottweil | Germany | ||
| 8 | Research Site | Giarre | CT | Italy | |
| 9 | Research Site | Genova | GE | Italy | |
| 10 | Research Site | Lido Di Camaiore | LU | Italy | |
| 11 | Research Site | Barakaldo (vizcaya) | Pais Vasco | Italy | |
| 12 | Research Site | Tivoli | RM | Italy | |
| 13 | Research Site | Sant'arsenio | SA | Italy | |
| 14 | Research Site | Sassari | SS | Italy | |
| 15 | Research Site | Borgomanero | Italy | ||
| 16 | Research Site | Catania | Italy | ||
| 17 | Research Site | Roma | Italy | ||
| 18 | Research Site | Torre Annunziata | Italy | ||
| 19 | Research Site | Salamanca | Castilla Leon | Spain | |
| 20 | Research Site | Zamora | Castilla Leon | Spain |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Eva Dencker Vansvik, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D1443L00082
- 2010-020579-21
Study Results
Participant Flow
| Recruitment Details | Patients were recruited at 20 study centres in 5 countries: Austria (1 site), Denmark (1 site), Germany (6 sites), Italy (9 sites) and Spain (3 sites). Recruitment started 2 November 2010 and was completed 29 June 2011. The last patient completed the study on 3 August 2011. |
|---|---|
| Pre-assignment Detail | Screening (0 days to 14 days before enrolment), enrolment at Visit 1 (14 days to 3 days prior to randomisation), randomisation at Visit 2 after confirmation of eligibility. 75 patients were screened/enrolled. Of these, 9 were not randomised; 2 patients due to own decision to discontinue and 7 patients due to eligibility criteria not fulfilled. |
| Arm/Group Title | First Seroquel XR Then Seroquel IR | First Seroquel IR Then Seroquel XR |
|---|---|---|
| Arm/Group Description | Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days | Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days |
| Period Title: Period 1, First Intervention | ||
| STARTED | 34 | 32 |
| COMPLETED | 31 | 29 |
| NOT COMPLETED | 3 | 3 |
| Period Title: Period 1, First Intervention | ||
| STARTED | 31 | 29 |
| COMPLETED | 31 | 29 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | First Seroquel XR Then Seroquel IR | First Seroquel IR Then Seroquel XR | Total |
|---|---|---|---|
| Arm/Group Description | Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days | Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days | Total of all reporting groups |
| Overall Participants | 34 | 32 | 66 |
| Age (participants) [Number] | |||
| between 18 and 29 years |
6
17.6%
|
3
9.4%
|
9
13.6%
|
| Between 30 and 50 years |
26
76.5%
|
28
87.5%
|
54
81.8%
|
| >50 years |
2
5.9%
|
0
0%
|
2
3%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
38.6
(8.2)
|
37.0
(5.2)
|
37.8
(6.9)
|
| Gender (participants) [Number] | |||
| Female |
11
32.4%
|
9
28.1%
|
20
30.3%
|
| Male |
23
67.6%
|
22
68.8%
|
45
68.2%
|
| Region of Enrollment (participants) [Number] | |||
| Spain |
1
2.9%
|
1
3.1%
|
2
3%
|
| Denmark |
1
2.9%
|
1
3.1%
|
2
3%
|
| Austria |
1
2.9%
|
2
6.3%
|
3
4.5%
|
| Germany |
18
52.9%
|
10
31.3%
|
28
42.4%
|
| Italy |
13
38.2%
|
18
56.3%
|
31
47%
|
Outcome Measures
| Title | Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance) |
|---|---|
| Description | Attentional standardised composite score: Standardised speed of performance score. Higher Score=better performance. Score range minus infinity to plus infinity. Measured at baseline (before study drug administration) and in Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. (Last test day not earlier than after 10 days of randomised)and in Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Last test day not earlier than after 10 days of crossover treatment. |
| Time Frame | Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per protocol set (PPS) is a subset of the FAS consisting of patients who fulfilled all inclusion criteria but none of the exclusion criteria, complied with study medication dosing scheme, did not violate any of the study restrictions and completed the study without protocol violation. |
| Arm/Group Title | Seroquel XR | Seroquel IR |
|---|---|---|
| Arm/Group Description | Patients that took Seroquel XR in arm XR-IR and arm IR-XR. | Patients that took Seroquel XR in arm XR-IR and arm IR-XR. |
| Measure Participants | 51 | 51 |
| Post 1 |
0.002
(0.856)
|
-0.098
(0.983)
|
| Post 2 |
-0.201
(1.054)
|
-0.131
(1.053)
|
| Post 3 |
-0.194
(1.040)
|
-0.120
(1.100)
|
| Title | Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) |
|---|---|
| Description | TSQM is a 14-item questionnaire with 4 sub-scales: effectiveness of the medication; treatment side effects; convenience of the medication; global satisfaction with the medication. Scale range 0-100 for each sub-scale, higher=greater satisfaction/milder side effects/greater convenience/greater overall satisfaction. There are 2 measurement, (after the start of taking study drug) one at end of period 1 and one at end of period 2. That is one measurement per patient per treatment. The mean of all the patients is presented, one mean value per treatment group. |
| Time Frame | Before taking study drug, end of Period 1 and end of Period 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS)used for efficacy analysis included all patients who in both study periods, received at least 1 dose of investigational product and for whom post-dose efficacy data was available. |
| Arm/Group Title | Seroquel XR | Seroquel IR |
|---|---|---|
| Arm/Group Description | Patients that took Seroquel XR in arm XR-IR and arm IR-XR. | Patients that took Seroquel IR in arm XR-IR and arm IR-XR. |
| Measure Participants | 60 | 59 |
| Side Effects |
87.9
(20.5)
|
81.5
(27.5)
|
| Effectiveness |
65.4
(16.8)
|
62.2
(19.1)
|
| Convenience |
66.2
(19.3)
|
63.6
(19.7)
|
| Overall Satisfaction |
63.0
(19.7)
|
58.9
(21.1)
|
| Title | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving |
|---|---|
| Description | International Shopping List Task (ISLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, higher score=better performance. Groton Maze Learning Test (GMLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, lower score=better performance. Lower=better performance. One Back memory task (ONB: measures working memory, min=minus infinity, max=plus infinity, lower score=better performance. |
| Time Frame | Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol (PPS), subset of the FAS consisting of patients who fulfilled all of inclusion but none of exclusion criteria, complied with study medication dosing, did not violate any of the restrictions and completed the study without protocol violation. |
| Arm/Group Title | Seroquel XR | Seroquel IR |
|---|---|---|
| Arm/Group Description | Patients that took Seroquel XR in arm XR-IR and arm IR-XR. | Patients that took Seroquel IR in arm XR-IR and arm IR-XR. |
| Measure Participants | 51 | 51 |
| ISLT post 1 |
24.020
(5.746)
|
23.588
(5.787)
|
| ISLT post 2 |
23.551
(4.899)
|
23.152
(5.562)
|
| ISLT post 3 |
23.216
(5.360)
|
22.920
(4.944)
|
| GMLT post 1 |
64.180
(29.822)
|
61.040
(28.721)
|
| GMLT post 2 |
59.021
(21.257)
|
56.956
(21.798)
|
| GMLT post 3 |
57.229
(24.162)
|
57.300
(22.307)
|
| ONB post 1 |
2.875
(0.143)
|
2.897
(0.134)
|
| ONB post 2 |
2.896
(0.151)
|
2.896
(0.169)
|
| ONB post 3 |
2.894
(0.161)
|
2.893
(0.154)
|
| Title | Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label |
|---|---|
| Description | The modified Bond-Lader VAS: The degree of sedation was marked by the patient on a 100 mm VAS ranging between Alert (=0 mm) and Drowsy (=100 mm). The marked length in millimetres. There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group. |
| Time Frame | Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS) used for analysis of efficacy included all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods. |
| Arm/Group Title | Seroquel XR | Seroquel IR |
|---|---|---|
| Arm/Group Description | Patients that took Seroquel XR in arm XR-IR and arm IR-XR. | Patients that took Seroquel IR in arm XR-IR and arm IR-XR. |
| Measure Participants | 60 | 60 |
| Mean (Standard Deviation) [units on a scale] |
23.5
(19.0)
|
28.6
(21.4)
|
| Title | Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label |
|---|---|
| Description | Stanford Sleepiness Scale: The sleepiness was assessed by the patient on a 7 item rating scale ranging from 1 (Feeling active and vital) to 7 (Almost in reverie). There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group. |
| Time Frame | Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS) used for analysis of efficacy included all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods. |
| Arm/Group Title | Seroquel XR | Seroquel IR |
|---|---|---|
| Arm/Group Description | Patients that took Seroquel XR in arm XR-IR and arm IR-XR. | Patients that took Seroquel IR in arm XR-IR and arm IR-XR. |
| Measure Participants | 60 | 60 |
| Mean (Standard Deviation) [units on a scale] |
2.4
(0.9)
|
2.6
(1.0)
|
| Title | Number of Dropouts. |
|---|---|
| Description | The number of patients who dropped out was counted. |
| Time Frame | Period 1 and Period 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety analysis set was used, that is all patients who received at least one dose of study medication and for whom any post-dose safety data are available were included in the safety set. |
| Arm/Group Title | Seroquel XR | Seroquel IR |
|---|---|---|
| Arm/Group Description | Patients treated with at least one dose of Seroquel XR | Patients treated with at least one dose of Seroquel IR |
| Measure Participants | 34 | 31 |
| Period 1 |
3
8.8%
|
2
6.3%
|
| Period 2 |
0
0%
|
0
0%
|
| Title | Mean Ratio of Morning Plasma Concentration of Quetiapine and Nor-quetiapine for Quetiapine IR and Quetiapine XR, at Steady-state Conditions in the End of Each Treatment Period 1 and 2. |
|---|---|
| Description | The ratio was derived as individual plasma concentration of quetiapine divided by the plasma concentration of nor-quetiapine. The mean ratio was derived for each treatment, XR and IR, respectively. |
| Time Frame | End of Period 1, end of Period 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 21 patients for the FAS were analysed. This outcome measure was introduced as a protocol amendment after study start and plasma concentration was not measured in all patients. FAS is all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods. |
| Arm/Group Title | Seroquel XR | Seroquel IR |
|---|---|---|
| Arm/Group Description | Patients that took Seroquel XR in arm XR-IR and arm IR-XR. | Patients that took Seroquel IR in arm XR-IR and arm IR-XR. |
| Measure Participants | 21 | 21 |
| Mean (Standard Deviation) [Ratio] |
1.941
(1.504)
|
2.128
(2.369)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Seroquel XR | Seroquel IR | ||
| Arm/Group Description | Patients treated with at least one dose of Seroquel XR | Patients treated with at least one dose of Seroquel IR | ||
All Cause Mortality |
||||
| Seroquel XR | Seroquel IR | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Seroquel XR | Seroquel IR | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/63 (0%) | 0/62 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Seroquel XR | Seroquel IR | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/63 (6.3%) | 4/62 (6.5%) | ||
| Blood and lymphatic system disorders | ||||
| neutropenia | 0/63 (0%) | 0 | 1/62 (1.6%) | 1 |
| Cardiac disorders | ||||
| tachycardia | 0/63 (0%) | 0 | 1/62 (1.6%) | 1 |
| Ear and labyrinth disorders | ||||
| vertigo | 1/63 (1.6%) | 1 | 0/62 (0%) | 0 |
| General disorders | ||||
| fatigue | 0/63 (0%) | 0 | 1/62 (1.6%) | 1 |
| Investigations | ||||
| heart rate increase | 0/63 (0%) | 0 | 1/62 (1.6%) | 1 |
| Nervous system disorders | ||||
| dizziness | 0/63 (0%) | 0 | 1/62 (1.6%) | 1 |
| sedation | 1/63 (1.6%) | 1 | 0/62 (0%) | 0 |
| somnolence | 1/63 (1.6%) | 1 | 2/62 (3.2%) | 2 |
| Psychiatric disorders | ||||
| delusion | 0/63 (0%) | 0 | 1/62 (1.6%) | 1 |
| psychotic disorder | 1/63 (1.6%) | 1 | 0/62 (0%) | 0 |
| sleep disorder | 1/63 (1.6%) | 1 | 0/62 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Gerard Lynch |
|---|---|
| Organization | Astra Zeneca |
| Phone | |
| ClinicalTrailTransparency@astrazeneca.com |
- D1443L00082
- 2010-020579-21