| CTRI Number |
CTRI/2010/091/001239 [Registered on: 03/12/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Other |
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Public Title of Study
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TRIOX: A post marketing study on the effects and safety of Trioptal in patients with newly diagnosed epilepsy |
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Scientific Title of Study
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The prospective, open-label, multicentre, non-comparative, observational post-marketing surveillance study evaluating efficacy and tolerability of TRIoptal® (OXcarbazepine) in children and adolescents with newly diagnosed partial seizures or generalized tonic-clonic seizures as monotherapy in routine clinical practice |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| CTRI476BIN01 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr Neeta Naik |
| Designation |
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| Affiliation |
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| Address |
Dr Yewale's Hospital & Vashi Criticare
Plot No 6B, Sector-9, Vashi
Mumbai
MAHARASHTRA
400703
India |
| Phone |
02224038008 |
| Fax |
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| Email |
neetanaik@yahoo.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Guliani |
| Designation |
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| Affiliation |
Medical Advisor |
| Address |
5th Floor Sandoz House, Shivsagar Estate
Dr A B Road, Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
02224958590 |
| Fax |
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| Email |
sameer.guliani@novartis.com |
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Details of Contact Person
Public Query
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| Name |
Dr Sameer Guliani |
| Designation |
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| Affiliation |
|
| Address |
5th Floor Sandoz House,
Dr A B Road, Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
02224958590 |
| Fax |
|
| Email |
sameer.guliani@novartis.com |
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Source of Monetary or Material Support
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| Novartis India Limited
Sandoz House, 5th floor
Shivsagar Estate
Dr. Annie Besant Road
India
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Primary Sponsor
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| Name |
Novartis India Limited
Sandoz House, 5th floor
Shivsagar Estate
Dr. Annie Besant Road
India
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| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neeta Naik |
Dr Yewale's Hospital & Vashi Criticare |
Dr Yewale's Hospital & Vashi Criticare,Plot No 6B, Sector-9, Vashi-400703
Mumbai
MAHARASHTRA |
02224038008
neetanaik@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Epilepsy (Newly Diagnosed partial seizures or generalized tonic clonic seizures), |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Oxcarbazepine |
24 weeks treatment.
Dose as per weight (10mg/kg/day) |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1. Male or female children & adolescents between 1 month to 18 years of age (both inclusive) with newly diagnosed epilepsy of the following types:
2.Partial seizures (including the seizure subtypes of simple and complex partial seizures, and partial seizures evolving to secondarily generalized seizures)
or Generalized tonic clonic seizures
3. Patients or their parent/legally-authorized guardian having given written, informed consent and/or assent after the nature of the trial had been fully explained (according to the local legal regulatory requirements)
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| ExclusionCriteria |
| Details |
1.Age less than 1 month or greater than 18 years;
2.Patients with evidence of severe or unstable physical illness or medical condition which would prevent them from participating in the clinical trial;
3.Any clinically significant abnormal laboratory findings during screening which remain abnormal upon repeated measurement;
4.Known hypersensitivity to Oxcarbazepine or any of the components in the formulation;
5. Any psychiatric coexistent illness that may affect the patient?s compliance with study procedures;
6. Patients with other indications than partial seizures, or generalized tonic-clonic seizures;
7. Parents or Guardians who are not willing to sign the Informed Consent form.
8. Females of child bearing potential who are planning to become pregnant or who are pregnant.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Other |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| Seizure Frequency: Reduction is seziure frequency from baseline to end of treatment. |
From baseline to end of study at 24 weeks |
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Secondary Outcome
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| Outcome |
TimePoints |
| Tolerability of the drug: Adverse Events and Serious Adverse Events |
From enrollment to end of study at 24 weeks |
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Target Sample Size
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Total Sample Size="500"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 4 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/06/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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