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1 Clinical Trial Details (PDF Generation Date :- Mon, 02 Jul :46:20 GMT) CTRI Number CTRI/2010/091/ [Registered on: 13/10/2010] - Last Modified On 26/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Active Controlled Trial CLINICAL TRIAL OF IN-AQUL-001 TO TREAT PRIMARY INSOMNIA IN ADULT & ELDERLY PATIENTS A Double Blind, Randomized, Parallel Group, Prospective, Multicentre Clinical Trial for Evaluation of Efficacy and Safety of IN-AQUL-001 in Comparison with Zopiclone in Adult and Elderly Patients with Primary Insomnia 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) CT/IN-AQUL-001/INSO/III/10 Designation Affiliation DCGI Details of Principal Investigator Dr Rajendra C Rane Sr Vice President Intas Pharma Phone Fax Designation Affiliation Intas Pharmaceuticals Ltd Chinubhai Center Ashram Road rane@intaspharma.com Details Contact Person (Scientific Query) Dr Jigar Katwala Medical adviser Intas Pharma Phone Fax Designation Affiliation Intas Pharmaceuticals Ltd Chinubhai Center Ashram Road jigar_katwala@intaspharma.com Details Contact Person (Public Query) Dr Dimple Shah Medical adviser Intas Pharma Intas Pharmaceuticals Ltd Chinubhai Center Ashram Road page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Intas Pharmaceuticals Limited, Ahmedabad Type of Sponsor Nil List of Countries of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details Intas Pharmaceuticals Limited Pharmaceutical industry-n of Site Site Phone/Fax/ Dr. Dhananjay Patil City Hospital City Hospital,1708/E, Rajarampuri 8 Lane, Main Road Kolhapur Dr Vivek Kirpekar Clinic Shar-hari Complex,20, Central bazar road, Ramdaspeth Dr. Abhay Jain Clinic 581, Bansi Palasa,M.G. Road- Indore Dr. B. S. V. Prasad Clinic Behind Hotel Vasco,Nasik road Not Applicable N/A Dr. Pali Rastogi Clinic Clinic-107, First Floor, Krishna Tower, Opp. Curewell Hospital,Janzeerwala Chouraha, New Palasia Indore Dr. Santosh Kumar Tandon Clinic 85, Tajul Masjid Road,- Bhopal Dr. Sudhir Bhave Clinic 5th Floor, Midas Height, Opp. Tarun Bharat Press,Central Bazaar Road, drpatildg@yahoo.co.in vivekanu@rediffmail.co m abhaynita@dataone.in bsvprasad2@rediffmail. com, bsvprasadz@gmail.com palirastogi@yahoo.co.in dr_sktandon@yahoo.co.in shbhave@gmail.com page 2 / 6

3 Details of Committee Dr. Hemang M Shah Department of Psychiatry, Civil Hospital Ramdaspeth E-1 ward, Department of Psychiatry, B J Medical College,Civil Hospital Dr. Ashish Goyal Doctor s house Doctor s house,6/7, North Raj Mohalla- Indore Dr. Kausar Abbasi Jeswani Hospital Jeswani Hospital, 2nd Floor, Parekh Centre,Opp. Daga Hospital, Gandhi Bag Dr. Mahesh Panchal Maanas Clinic Maanas Clinic, 201, 2nd floor, Aastha Complex,Prabhat Chawk, Ghatlodiaya Dr Vikas Bhute Parivartan Manorugnalaya Parivartan Manorugnalaya,7, Hindustan Colony, Wardha Road Dr. Arun Y. Kulkarni Patanjali Clinic Patanjali Clinic 3237, A ward Mahadwar Road-Gujri Corner,,Opp Jain Mandir Kolhapur Dr. Vasudeo Pralhad Surya Hospital Surya Hospital Pvt Ltd.,1317, Kasba Peth Pune Dr. Vaibhav Dubey V Care psychiatry clinic V Care psychiatry clinic,near Kilol Park Petrol Pump, Near SBI ATM Bhopal drhemangshah@yahoo. co.in , drashish.goyal@yahoo. com drksabbasi@gmail.com drpanchal29@hotmail.c om drvikasbhute@gmail.co m arunyk9@yahoo.com , vasudeoparlikar@yaho o.co.in dr.vaibhavdubey@gmai l.com of Committee Approval Status Date of Approval Is Independent Committee? Convenient Hospitals Limited Committee/Indore for Dr. Abhay Jain Approved 27/10/2010 No page 3 / 6

4 for Dr Vikas Bhute for Dr Vivek Kirpekar for Dr. Arun Y. Kulkarni for Dr. B. S. V. Prasad for Dr. Dhananjay Patil for Dr. Kausar Abbasi for Dr. Mahesh Panchal for Dr. Pali Rastogi for Dr. Santosh Kumar Tandon for Dr. Sudhir Bhave for Dr. Vaibhav Dubey for Dr. Vasudeo Paralikar Committee/Ahm edabadfor Dr. Ashish Goyal The Committee B J Medical college & Civil Approved 25/10/2010 No page 4 / 6

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Hospital/Ahmedabad - Dr. Hemang M. Shah Status Date Approved/Obtained 20/09/2010 Health Type Patients Condition Primary Insomnia in adult & elderly patients Type Details Intervention IN-AQUL-001 Start as one tablet at night and if required escalate to two tablets at first follow-up visit. (30 minutes before lying down to sleep for a period of 2 weeks of treatment). Comparator Agent Zopiclone 3.75 mg oral tablet Start as one tablet at night and if required escalate to two tablets at first follow-up visit. (30 minutes before lying down to sleep for a period of 2 weeks of treatment). Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Patients with: 1)Either sex 18 to 75 years of age 2)Primary insomnia as defined by the DSM-IV for at least 1 month. 3)Mean subjective 1) LSO? 20 minutes; 2) WASO? 60 minutes; 3) TST? 390 minutes, based on sleep diary recorded during placebo run-in period 4)Female patients of childbearing potential: nonpregnant, nonlactating, with negative serum pregnancy test at screening and willing to utilize an acceptable method of contraception throughout the study period. 5)Willing to provide written informed consent Exclusion Criteria Details Exclusion Criteria Patients with: 1)Disease associated:?history of sleep apnea syndrome?concomitant history of cognitive disorders, depression, schizophrenia, panic disorder, dementia, chronic pain, glaucoma, frequent nightly urination, significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, metabolic disorders?history of suicidal tendency, fibromyalgia, seizures (excluding childhood febrile seizures), and chronic obstructive pulmonary disease. 2)Drug associated:?known hypersensitivity to any of study medications;?has participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of study medication?is required to take or intends to continue taking any disallowed medication or any prescription medication or over-the counter medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication,?has used any central nervous system medication or other drugs or supplements known to affect sleep pattern within 1 week prior to the administration of double-blind study medication.?history of drug induced leucopenia/neutropenia/agranulocytosis 3)Investigations associated:?serious hepatic disease (SGPT/OT 2.5 times UNL) page 5 / 6

6 Powered by TCPDF ( PDF of Trial Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Participant, Investigator and Outcome Assessor Blinded?Cardiac arrhythmia, QT prolongation or conditions predisposing for prolongation of QT interval?hyperglycemia (Random blood sugar 140 mg/dl) or diabetes mellitus?has any other clinically important abnormal finding 4)Requirement of sleep schedule changes as a part of his professional duty. 5)History of substance abuse including tobacco, alcohol and caffeine 6)As deemed inappropriate for enrollment by investigating physician due to other reasons. Primary Outcome Outcome Timepoints Change in the WASO (Wake time after sleep onset) At end of the study Secondary Outcome Outcome Timepoints (1) latency to sleep onset (LSO) (2) Total sleep time (TST) (3) Sleep efficiency (SE) At end of the 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) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=280 Sample Size from =280 16/10/ /10/2010 Years=0 Months=6 Days=0 Not Applicable Completed Nil This trial has been designed to evaluate the efficacy and safety of IN-AQUL-001 with Zopiclone in the treatment of primary insomnia in adult and elderly patients. It is reasonably expected that IN-AQUL-001 will prove to be safe and effective treatment option in the treatment of primary insomnia. The trial will be conducted in adult & elderly n patients only and within only. Anticipated date for first patient enrolment in the study is 3rd week of October page 6 / 6