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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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9 October 2012 |
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Main ID: |
EUCTR2007-007669-20-DE |
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Date of registration:
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12/03/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Scientific title:
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A Double-Blind, Multiple Dose Titration Study to Investigate the Safety,
Tolerability and Pharmacokinetics of Once Daily and Twice Daily Doses of
JNJ-37822681 in Male and Female Patients With Stable Schizophrenia
Protocol 37822681SCH2003; Phase IIa
EudraCT Number: 2007-007669-20
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Date of first enrolment:
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18/08/2008 |
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Target sample size:
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36 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007669-20 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
Other trial design description: multi-center, multiple dose titration study
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Other specify the comparator: Compare qd with bid
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Phase:
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Countries of recruitment
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Belgium
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Germany
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
·Male or female between 18 and 65 years of age, inclusive
·Female subjects must meet one of the following:
–postmenopausal (for at least 12 months),
–Surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy)
–abstinent (per investigator’s judgement),
–if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel], male partner sterilization),
before entry, and must agree to continue to use the same method of contraception throughout the study.
·Women of childbearing potential must have a negative serum b human chorionic gonadotropin (b hCG) pregnancy test at screening and admission
·Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. For men that have been clinically determined to be infertile, this restriction is for 5 days after receiving the last dose of study drug.
·In- or outpatients with schizophrenia stably treated for at least 6 months with antipsychotic monotherapy (£ 200mg/d chlorpromazine equivalent dose) or stable for at least 3 months without drug therapy
·PANSS at screening < 60
·In the opinion of the investigator and in compliance with local regulations, the subject can be withdrawn from current antipsychotic medication.
·A known (by the site) history of schizophrenia of at least 12 months
·BMI between 18 and 35 kg/m2 inclusive (BMI = weight/height2)
·Willing to be hospitalized during the double-blind treatment period of the study (up to Day 15).
·Willing to adhere to the prohibitions and restrictions specified in this protocol
·Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
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:
·A DSM-IV axis I diagnosis other than schizophrenia
·A DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
·Any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn’s disease, liver disease, or renal disease
·Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases
·History of neuroleptic malignant syndrome (NMS)
·Other significant and/or unstable systemic illnesses
·Allergy or hypersensitivity to any known antipsychotic compounds
·Inability to swallow the study medication whole with the aid of water (subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile)
·Exposure to an experimental drug or experimental medical device within 90 days before screening
·Significant risk of suicidal or violent behavior
·Female subjects who are pregnant or breastfeeding
·Alanine aminotransferase or aspartate aminotransferase levels more than 2 times the upper limit of normal
·Other biochemistry, hematology, or urinalysis results that are not within the laboratory’s reference range, and that are deemed by the investigator to be clinically significant
·Use of beta-blockers (if used for any indication other than hypertension and still present at baseline)
·Injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
·Use of fluoxetine or monoamine oxidase inhibitors within 4 weeks before screening
·Use of all other antidepressants, anticonvulsants, or lithium within 2 weeks before baseline
·Received electroconvulsive therapy within 3 months before screening
·Have been involuntarily committed to psychiatric hospitalization
·Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study
·Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Product Name: JNJ-37822681/F002
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Evaluate the safety, tolerability, and PK of JNJ-37822681 in patients with schizophrenia in the predicted clinical dose range.
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Main Objective: The primary objective is to investigate the safety and tolerability of JNJ-37822681 administered as qd or bid following a dose titration in male and female patients with stable schizophrenia.
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Secondary Objective: The secondary objectives of this study include:
• To investigate the plasma pharmacokinetic (PK) profile of JNJ-37822681 administered as once
daily (qd) or twice daily (bid) in male and female patients with stable schizophrenia;
• To investigate the effect of JNJ-37822681 on plasma prolactin (PRL) levels.
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Secondary ID(s)
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37822681SCH2003
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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