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A randomised, double-blind, placebo- and olanzapine- controlled, parallel-group study to evaluate the efficacy and safety of 3 fixed doses of S 33138 in treatment of patients with an acute episode of Schizophrenia. A phase IIb, international, multicentre, 8-week study

A randomised, double-blind, placebo- and olanzapine- controlled, parallel-group study to evaluate the efficacy and safety of 3 fixed doses of S 33138 in treatment of patients with an acute episode of Schizophrenia. A phase IIb, international, multicentre, 8-week study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006184-23-SK
Enrollment
480
Registered
2008-04-18
Start date
2008-01-11
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia MedDRA version: 10.0 Level: LLT Classification code 10039626 Term:

Interventions

Product Name: S33138 Product Code: S33138 Pharmaceutical Form: Film-coated tablet Current Sponsor code: S33138 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- P

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inpatients between 18 and 50 years of age (included), male or female, hospitalised for an acute episode of schizophrenia (relapse or recurrence). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient presenting a first episode of schizophrenia. Women of childbearing potential or women who have been post menopausal for less than 2 years without effective contraception (implants, injectables, combined oral contraceptive method, intra-uterine devices, sexual abstinence or vasectomised partner) as well as pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the antipsychotic efficacy of S 33138 compared to placebo;Secondary Objective: To assess the safety of S 33138, the pharmacokinetics of S 33138 and its main metabolite S 35424 and the patients’ global functioning;Primary end point(s): PANSS total score—

Countries

Slovakia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026