CTRI/2013/10/004071
Completed
Phase 4
A prospective, open-label, multicentre, non-comparative, post marketing observational study evaluating effectiveness and tolerability of Carbamazepine (TEgrital®) As Monotherapy in treatment naïve patients with generalized tonic-clonic seizures in routine clinical practice in India. - TEAM study
ovartis India Limited0 sites493 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Naïve patients with generalized tonic-clonic seizures
- Sponsor
- ovartis India Limited
- Enrollment
- 493
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and female out patients \> 1 year to \< 60 years of age with diagnosis of generalized tonic\-clonic seizures that have been prescribed Carbamazepine as monotherapy (in OAED naïve patients) as per local prescribing information.
- •2\.Patients or their parent/legally\-authorized guardian having given written, informed consent and/or assent to have their data collected after the nature of the trial had been fully explained (according to the local legal regulatory requirements). Patients will not need to consent for taking the drug, as their treatment is decided before entry into the study and is part of their medical care.
- •3\.Patients who agree to follow medication as per local prescribing information of the study drug while participating in the study.
Exclusion Criteria
- •Patients who meet any of the following criteria are not eligible for inclusion in this study:
- •1\.Patients with absence seizure or with juvenile myoclonic seizure.
- •2\.Patients who require two or more anti\-epileptic drug.
- •3\.Patients with any psychiatric coexistent illness that may affect the patientâ??s compliance with study procedures.
- •4\.Known hypersensitivity to the study drug, excipients or to drugs of similar chemical classes.
- •5\.Pregnant or nursing (lactating) women.
- •6\.Women of child\-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method (if accepted by local ethics committee) or a barrier method plus a hormonal method.
- •Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
- •Reliable contraception should be maintained throughout the study and for 7 days after the study.
- •Woman are considered post\-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels 40 mIU/ml \[for US only: and estradiol 20 pg/ml] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow\-up hormone level assessment.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 4
A post marketing surveillance study evaluating effectiveness and tolerability of Trioptal® (Oxcarbazepine) in patients with generalized tonic-clonic seizures as monotherapy in routine clinical practice in IndiaHealth Condition 1: null- Patients with generalized tonic-clonic seizures.CTRI/2012/12/003238ovartis India Ltd500
Active, not recruiting
Phase 1
This is a non-comparative study that aims to evaluate and confirm the effects of the Effimia® contraceptive pill on intermenstrual bleeding.Combined Oral Contraceptives (COC)MedDRA version: 20.0Level: SOCClassification code 10014698Term: Endocrine disordersSystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]EUCTR2021-003027-15-ITITALFARMACO S.P.A.228
Recruiting
Phase 4
TRIOX: A post marketing study on the effects and safety of Trioptal in patients with newly diagnosed epilepsyCTRI/2010/091/001239ovartis India LimitedSandoz House, 5th floorShivsagar EstateDr. Annie Besant RoadIndia500
Active, not recruiting
Not Applicable
A prospective, multicentre, open-label, centrally allocated, active-controlled, phase 2 study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alone in advanced / metastatic epithelial ovarian cancer patients in second line being refractory to first line platinum treatment or in third lineAdvanced/metastatic epithelial ovarian cancer in second line being refractory to first line platinum treatment or in third lineMedDRA version: 17.1Level: PTClassification code 10033158Term: Ovarian epithelial cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-000491-14-ESAB Science56
Active, not recruiting
Phase 1
Study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alone in advanced / metastatic epithelial ovarian cancer patients in second line being refractory to first line platinum treatment or in third line.Advanced/metastatic epithelial ovarian cancer in second line being refractory to first line platinum treatment or in third lineMedDRA version: 20.0 Level: PT Classification code 10033158 Term: Ovarian epithelial cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-000491-14-SKAB Science80