Phase IIA study in patients with schizophrenia

Study identifier:D0970C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD2624 in Adult Schizophrenia Patients

Medical condition

schizophrenia

Phase

Phase 2

Healthy volunteers

Study drug

AZD2624, Olanzapine, Placebo

Sex

All

Actual Enrollment

106

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 May 2008

Primary Completion Date: 01 Mar 2009

Study Completion Date: 01 Mar 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Rockville, MD, United States

Arms	Assigned Interventions
Experimental: AZD2624 AZD2624 40 mg	Drug: AZD2624 Oral Suspension
Other: Olanzapine Olanzapine 15 mg	Drug: Olanzapine PO BID Other Name: Zyprexa
Placebo Comparator: Placebo Matching Placebo	-

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 2 centers in the US were initiated and enrolled patients. 159 patients enrolled, of which 106 randomized

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened up to 21 days, and admitted to the Clinical Research Unit (CRU) for a maximum of 2 days until eligibility was determined. Once eligibility was determined, patients currently on medication entered a 7 days washout period, patients not currently on medication had a 3 day washout, prior to randomization to study medication.

Reporting Groups

	Description
AZD2624	AZD2624 40 mg
Placebo	Matching Placebo
Olanzapine	Olanzapine 15 mg

Participant Flow: Overall Study

	AZD2624	Placebo	Olanzapine
STARTED	43^[1]	41^[2]	22^[3]
Randomized	43	41	22
Received Treatment	43	41	22
Eligible for Efficacy Analysis	42	39	21
Completed scheduled treatment	30	33	18
COMPLETED	30	33	18
NOT COMPLETED	13	8	4
Adverse Event	3	2	1
Withdrawal by Subject	2	1	2
Lack of Efficacy	7	5	0
Not specified	0	0	1
Safety Reasons	1	0	0

[1]	Randomized & received study medication
[2]	Randomized & received study medication
[3]	Randomized & received study medication

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
AZD2624	AZD2624 40 mg
Placebo	Matching Placebo
Olanzapine	Olanzapine 15 mg

Baseline Measures

	AZD2624	Placebo	Olanzapine	Total
Number of Participants [units: Participants]	43	41	22	106
Age Continuous [units: Year] Mean ± Standard Deviation	40.1 ± 12	40.2 ± 11.6	35.3 ± 8.7	39.2 ± 11.3
Gender, Male/Female [units: Participants]
Female	3	2	0	5
Male	40	39	22	101

Outcome Measures

1. Primary Outcome Measure: Positive and Negative Syndrome Scale (PANSS) total score change from baseline [ Time Frame: Baseline, Day 28 ]

Measure Type	Primary
Measure Name	Positive and Negative Syndrome Scale (PANSS) total score change from baseline
Measure Description	PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.
Time Frame	Baseline, Day 28
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
AZD2624	AZD2624 40 mg
Placebo	Placebo
Olanzapine	Olanzapine 15 mg

Measured Values

	AZD2624	Placebo	Olanzapine
Number of Participants Analyzed [units:participants]	42	39	21
Positive and Negative Syndrome Scale (PANSS) total score change from baseline [units: Points on a scale] Mean (Standard Error)	1.40 (2.27)	4.51 (2.35)	-8.79 (3.2)

No statistical analysis provided for Positive and Negative Syndrome Scale (PANSS) total score change from baseline

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
AZD2624	AZD2624 40 mg
Placebo	Matching Placebo
Olanzapine	Olanzapine 15 mg

Serious Adverse Events

AZD2624

Placebo

Olanzapine

Total, serious adverse events

# participants affected / at risk

4/43 (9.30%)

2/41 (4.88%)

0/22 (0.00%)

Psychiatric disorders

Psychotic disorder¹,^†

# participants affected / at risk

4/43 (9.30%)

2/41 (4.88%)

0/22 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.1
2	Term from vocabulary,

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
AZD2624	AZD2624 40 mg
Placebo	Matching Placebo
Olanzapine	Olanzapine 15 mg

Other Adverse Events

AZD2624

Placebo

Olanzapine

Total, other (not including serious) adverse events

# participants affected / at risk

29/43 (67.44%)

27/41 (65.85%)

18/22 (81.82%)

Nervous system disorders

Headache¹,^†

# participants affected / at risk

7/43 (16.28%)

0/41 (0.00%)

3/22 (13.64%)

Investigations

Weight Increased¹,^†

# participants affected / at risk

0/43 (0.00%)

0/41 (0.00%)

9/22 (40.91%)

Nervous system disorders

Sedation¹,^†

# participants affected / at risk

4/43 (9.30%)

1/41 (2.44%)

3/22 (13.64%)

Nervous system disorders

Somnolence¹,^†

# participants affected / at risk

3/43 (6.98%)

1/41 (2.44%)

4/22 (18.18%)

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

6/43 (13.95%)

1/41 (2.44%)

1/22 (4.55%)

Musculoskeletal and connective tissue disorders

Musculoskeletal Pain¹,^†

# participants affected / at risk

1/43 (2.33%)

5/41 (12.20%)

1/22 (4.55%)

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

5/43 (11.63%)

1/41 (2.44%)

1/22 (4.55%)

Psychiatric disorders

Psychotic Disorder¹,^†

# participants affected / at risk

4/43 (9.30%)

3/41 (7.32%)

0/22 (0.00%)

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

1/43 (2.33%)

4/41 (9.76%)

1/22 (4.55%)

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

1/43 (2.33%)

4/41 (9.76%)

0/22 (0.00%)

Metabolism and nutrition disorders

Increased Appetite¹,^†

# participants affected / at risk

0/43 (0.00%)

1/41 (2.44%)

4/22 (18.18%)

Gastrointestinal disorders

Stomach Discomfort¹,^†

# participants affected / at risk

2/43 (4.65%)

3/41 (7.32%)

0/22 (0.00%)

Metabolism and nutrition disorders

Decreased Appetite¹,^†

# participants affected / at risk

3/43 (6.98%)

1/41 (2.44%)

0/22 (0.00%)

Musculoskeletal and connective tissue disorders

Back Pain¹,^†

# participants affected / at risk

0/43 (0.00%)

3/41 (7.32%)

0/22 (0.00%)

Gastrointestinal disorders

Dry Mouth¹,^†

# participants affected / at risk

0/43 (0.00%)

0/41 (0.00%)

2/22 (9.09%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.1
2	Term from vocabulary,

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	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.
	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 more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Gerard Lynch
Organization:	Astrazeneca
E-mail:	[email protected]

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=245&filename=CSR-D0970C00004.pdf
Download
CSR-D0970C00004.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Dhaval Desai

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=245&filename=CSR-D0970C00004.pdf

CSR-D0970C00004.pdf

Trial Results Summaries