SOLIACS: Solian Solution in the Acute Setting | NCT00245674

Studies
SOLIACS: Solian Solution in the Acute Setting

NCT00245674

Sponsor

Sanofi

Status

Completed

Last Update Posted

Apr 10, 2008Estimated

Enrollment

300

Phase

Phase 4

Conditions

Schizophrenia

Interventions

amisulpride

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT # : 2004-004461-15

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 27, 2005

First Submission Date that Met QC Criteria

Oct 27, 2005

First Posted Date

Oct 28, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2008

Last Update Posted Date

Apr 10, 2008Estimated

Description Module

Brief Summary

During this study the efficacy and safety profile will be evaluated of the use of amisulpride in the form of a solution in schizophrenic patients with an acute episode.

The main purpose of the study is to observe the anti-psychotic effect of amisulpride as a solution during the first days of an acute episode of schizophrenia.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Name	Type	Description	Arm Group Labels	Other Names
amisulpride	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
*analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.

Secondary Outcomes

Measure	Description	Time Frame
*analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

schizophrenic in-patients with an acute episode
aged between 18 and 65 years
written informed consent

Exclusion Criteria:

pregnancy and breast-feeding
breast cancer, prolactinoma, pheochromocytoma
hypersensitivity to amisulpride or one of the other excipients
contra-indications when using amisulpride as per the SmPC

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dr. Christian Fassotte, M.D.	Sanofi	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077582	Amisulpride

Ancestor Terms

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146

Browse Leaves

Not provided

Browse Branches

Not provided