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1 Clinical Trial Details (PDF Generation Date :- Wed, 26 Dec :53:59 GMT) CTRI Number Last Modified On 01/11/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/05/ [Registered on: 17/05/2012] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Active Controlled Trial Phase III efficacy trial of Buspirone with comparison to Sertraline in treatment of General Anxiety Disorder PHASE III, PROSPECTIVE, OPEN LABEL, PARALLEL, MULTICENTER, RANDOMIZED CLINICAL TRIAL FOR COMPARATIVE EVALUATION OF EFFICACY AND SAFETY OF BUSPIRONE (ANSITEC ) AND SERTRALINE IN THE TREATMENT OF GENERALIZED ANXIETY DISORDER (GAD) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) LB1005 (Version: 1.0 Dated: 27/Dec/2011) Designation Affiliation Protocol Number Details of Principal Investigator Prasann Bavania Senior Research Associate Phone Fax Designation Affiliation Accutest Research Laboratories (I) Pvt. Ltd. Opp. Hotel Grand Bhagwati, S.G. Highway, Bodakdev, Ahmedabad prasann.bavania@accutestindia.com Details Contact Person (Scientific Query) Dr Agam Shah Lead Research Coordinator Phone Fax Designation Affiliation Accutest Research Laboratories (I) Pvt. Ltd. Opp. Hotel Grand Bhagwati, S.G. Highway, Bodakdev, Ahmedabad agam.shah@accutestindia.com Details Contact Person (Public Query) Prasann Bavania Phone Accutest Research Laboratories (I) Pvt. Ltd. Opp. Hotel Grand Bhagwati, S.G. Highway, Bodakdev, Ahmedabad page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax Source of Monetary or Material Support > LIBBS FARMACUTICA LTDA Rua Josef Kryss, 250, Barra Funda, São Paulo SP Brazil Type of Sponsor NIL List of Countries of Principal Investigator Primary Sponsor Details LIBBS FARMACUTICA LTDA Rua Josef Kryss, 250, Barra Funda, São Paulo SP Brazil Pharmaceutical industry-global NIL of Site Site Phone/Fax/ Dr Nehalkumar Shah Vraj 2nd Floor, 24 Carat, Ramnagar Chowk, Sabarmati, Ahmedabad Dr Bhavesh Lakdawala B. J. Medical College & Civil, Dept. of Psychiatry drnehalshah@indiatime s.com Dept. of Psychiatry, E Ward, B.J.Medical College & Civil, dr_bmlakdawala@yaho Asarwa, Ahmedabad - o.co.in Dr Vaishal Vora Sneh Clinic , Nakshatra Complex, Above HDFC Bank, Maninagar Cross Road, Maninagar, Ahmedabad Dr Bakul Buch Hatkesh Healthcare Foundation Hatkesh Healthcare Foundation, Opp. Bhutnath Temple, College Road, Junagadh Junagadh Dr Vijay Nagecha Nagecha Creative Chamber, Kanak Road, Behind Bus Stand, Rajkot Rajkot Dr Rajeshkumar C Maniar Dr Hitendra Gandhi GIPS & Research Centre, V. S. General, Department of vnvora@gmail.com bakulbuch@gmail.com nagecha@rediffmail.co m Shreenath Complex, Umiya Vijay Road, Opp. Punit Nagar-1, Satellite, rcmaniar@yahoo.com Ahemdabad Room No-14, Arogay Bhuvan, Department of page 2 / 7

3 Details of Ethics Committee Dr Jay Kumbhani Psychiatry Manas & deaddiction centre Psychiatry, V.S.General, Ellisebridge, Ahmedabad /03, Manthan Point, Opp. Amisha Hotel, Unapani Road, Laldarwaja, Surat Surat Dr Timir Shah Divyam 46/A, Maher Park, Athwagate, Ring Road, Surat Surat Dr Rohan Kusumgar Aashray Clinic 114, Spam Trade Centre, Opp. Kocharab Aashram, Nr.Paldi Cross Road, Elishbridge, Ahmedabad Dr Sabyasachi Mitra Dr Sanjay jain Calcutta Medical Research Institute SMS Medical College & Dr Kalyan Chakravarthy Mediciti 7/2 Diamond Harbour Road, Kolkata Kolkata WEST BENGAL J.L.N. Marg, Jaipur Jaipur RAJASTHAN , Secretariat Road, Hyderabad Hyderabad ANDHRA PRADESH Dr Jagadish Anjanappa Abhaya 17, Dr. M. H. Marigowda Road (Hosur Road), Opp. 9th Cross, Bus Stop, Wilson Garden, Bangalore Bangalore KARNATAKA m mail.com l.com com m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Abhaya Ethics Committee, Abhaya CMRI Ethical Committee, The Calcutta Medical Research Institute Ethical Committee, Sheth V.S. General Approved 23/07/2012 No Approved 22/06/2012 No Approved 17/05/2012 No page 3 / 7

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Ethics Committee SMS Medical College & Independent Ethical Review Committee of Surat for Divyam Independent Ethical Review Committee of Surat for Manas & deaddiction centre Independent Ethics Committee -Aditya for Sneh Clinic Independent Ethics Committee -Aditya for Vraj Mediciti Ethics Committee, Mediciti Sashvat for Hatkesh Healthcare Foundation Sashvat for Nagecha Siddhant Independent Ethics Committee for Ashray Clinic Siddhant Independent Ethics Committee for GIPS & Research Centre The Institutional Ethics Committee of B. J. Medical College & Civil, Ahmedabad Status Approved 05/10/2012 No Approved 09/02/2012 Yes Approved 09/02/2012 Yes Approved 21/01/2012 Yes Approved 21/01/2012 Yes Approved 26/07/2012 No Approved 16/02/2012 Yes Approved 16/02/2012 Yes Approved 13/02/2012 Yes Approved 13/02/2012 Yes Approved 29/02/2012 No Date Approved/Obtained 09/05/2012 Health Type Patients Condition GENERALIZED ANXIETY DISORDER Type Details Intervention BUSPIRONE (ANSITEC) of Libbs Farmaceutica Ltda, Brazil INITIAL DOSE (V1): 10mg/day (titration) (5mg 2 times per day) FULL TREATMENT DOSE (V2): 15mg/day (5mg 3 times per day) Further adjustment of the dose will be permitted on two occasions during the study, at V3 and V4, and these adjustments can be: 15mg to 20mg/day and subsequently from 20mg to 30mg/day, if applicable. Duration of Treatment: 14 weeks page 4 / 7

5 Inclusion Criteria Comparator Agent Age From Age To Gender Details SERTRALINE (DAXID) of Pfizer Ltd., Year(s) Year(s) Both Inclusion Criteria INITIAL DOSE (V1): 25mg/day (titration) (once daily) FULL TREATMENT DOSE (V2): 50mg/day (once daily) Further adjustment of the dose will be permitted on two occasions during the study, at V3 and V4, and these adjustments can be: 50mg to 100mg/day and subsequently from 100mg to 150mg/day, if applicable. Duration of Treatment: 14 weeks 1)Men and women aged between 18 and 65 years with a diagnosis of GAD as per DSM-IV-TR. 2)Women without child bearing potential (for example, surgically sterilized or post-menopausal for at least 1 year) or women that are not pregnant (confirmed by?-hcg test at screening) or lactating and agreeing to use a contraceptive method accepted by the investigator during the study conduction. 3)Willing to give written informed consent before any procedure in the study has been conducted. (For application of the ICF refers to item 11.2) 4)Score? 18 on the Hamilton Anxiety Scale (HAM-A) at screening and randomization visit. Exclusion Criteria Details Exclusion Criteria 1)Previous history of an inadequate response to buspirone and/or sertraline Inadequate response: no response to the treatment with the use of the full dose of buspirone (15 mg/day) or sertraline (50 mg/day) for at least 4 weeks of use. 2)Allergy or known hypersensitivity to buspirone or sertraline 3)Current diagnosis of Axis I disorders, other than GAD, and/or borderline, antisocial personality disorders as per DSM-IV-TR; 4)Diagnosis of convulsive disorders within the last 6 months (for example: epilepsy, epilepticus, cranial trauma) and/or current use of anticonvulsants 5)Serious organic cerebral syndromes 6)Patients with an uncontrolled and unstable clinical state considered clinically significant (e.g. renal, hepatic, endocrine, respiratory, cardiovascular, hematological, immunological or cerebrovascular disease or malignant neoplasm) which may interfere in the interpretation of the safety and efficacy evaluations in accordance with the investigator s opinion 7)Patients with narrow-angle glaucoma 8)Regular use of the following medication: Selective serotonin reuptake inhibitors in the last 28 days prior to date of randomization; Anxiolytics, antipsychotics/neuroleptics, MAO inhibitors, mood stabilizers, anticonvulsants or other antidepressants in the last 14 days prior to date of randomization Central nervous system stimulants and hypnotics (except for selective GABA(A) receptor alpha1 subunit agonists, such as zolpidem), betablockers, clonidine, sumatriptan, antihistamines that page 5 / 7

6 cause sedation, phytotherapeutics with an anxiolytic action in the last 7 days prior to date of randomization Regular Use: for this protocol is considered as the use of the medication described above for a period greater than or equal to 07 consecutive days Sporadic Use: is considered as the use of the medication described above for a period less than 07 consecutive days and patients with sporadic medication use can be included on trial if the medication use was stopped at least 7 days prior to randomization date. The frequency of use, dose and half-life of each drug must be considered in defining the sporadic use and justified on source documents by investigator; 9)Treatment for hyperthyroidism or hypothyroidism initiated, modified or interrupted within last 3 months 10)Psychotherapy treatment initiated or interrupted within last 3 months (Patients that have been in psychotherapy treatment for more than 3 months can be enrolled in the study provided they proceed with psychotherapy during the entire study and, if psychotherapy is required to be interrupted, the patient should be withdrawn from the study) 11)History of alcohol or illegal drug dependence within last 1 year 12)Participation in another clinical study or usage of any investigational product/ device within last 30 days 13)Patients who in the opinion of the principal investigator may not present adherence to the study treatment. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization An Open list of random numbers Outcome Assessor Blinded Primary Outcome Outcome Timepoints Total HAM-A score 9 weeks Secondary Outcome Outcome Timepoints 1. Total HAM-A score 2. Treatment responders 3. Remissions 4.Total ZSRAS Score 5.CGI- I, 6.CGI-S, E 7.Total PSWQ Score 8.The general impression of Investigator 9.The general impression of patient 10.discontinuations due to low efficacy 1.at 1, 4, 6 and 9 weeks 2.at 1, 4, 6 and 9 weeks 3.at 4, 6 and 9 weeks 4.at 1, 4, 6 and 9 weeks 5.at 1, 4, 6 and 9 weeks 6.at 1, 4, 6 and 9 weeks 7.at 1, 4, 6 and 9 weeks 8. 9 weeks 9. 9 weeks 10. throughout study Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Total Sample Size=114 Sample Size from =114 11/06/2012 No Date Specified Years=1 Months=0 Days=0 Not Applicable page 6 / 7

7 Powered by TCPDF ( PDF of Trial Recruitment Status of Trial () Publication Details Brief Summary Completed The objective of this study is to compare the efficacy and safety of Buspirone in relation to Sertraline in patients with GAD. This study will be conducted in accordance with current applicable local regulations guideline, with the good clinical practice standards established in the International Harmonization Conference (ICH-GCP), and the principles of the Helsinki Declaration. Written consent will be obtained by all trial patients before undertaking any procedure. page 7 / 7