REFCTRI/2009/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Thu, 01 Feb :18:01 GMT) CTRI Nuber CTRI/2009/091/ [Registered on: 24/06/2009] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Randoized, Parallel Group, Active Controlled Trial A Multicenter, Multinational, Randoized, Open-Label, Parallel-Group Trial to Evaluate the Safety of Fentanyl TAIFUN Treatent after Titrated Dose Adinistration and the Current Breakthrough Pain Treatent for Breakthrough Pain in Cancer Patients on Maintenance Opioid Therapy" A Multicenter, Multinational, Randoized, Open-Label, Parallel-Group Trial to Evaluate the Safety of Fentanyl TAIFUN Treatent after Titrated Dose Adinistration and the Current Breakthrough Pain Treatent for Breakthrough Pain in Cancer Patients on Maintenance Opioid Therapy. (FIND S) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (ulti-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) CL_700_014_PRO EUDRA CT no Designation Affiliation Protocol Nuber EudraCT Details of Principal Investigator Dr. Dilip Pawar Phone Fax Eail Designation Affiliation Akela Clinical Research Pvt. Ltd 202, Wellington Business Park, Marol Naka, Andheri- Kurla Road, Andheri (East) dpawar@akelaphara.co Details Contact Person (Scientific Query) Dr. Dilip Pawar Phone Fax Eail Designation Affiliation Akela Clinical Research Pvt. Ltd 202, Wellington Business Park, Marol Naka, Andheri- Kurla Road, Andheri (East) dpawar@akelaphara.co Details Contact Person (Public Query) Dr. Dilip Pawar Akela Clinical Research Pvt. Ltd 202, Wellington Business Park, Marol Naka, Andheri- Kurla Road, Andheri (East) page 1 / 6

2 Source of Monetary or Material Support Priary Sponsor Details of Secondary Sponsor Countries of Recruitent Sites of Study Phone Fax Eail dpawar@akelaphara.co Source of Monetary or Material Support > Akela Phara INC Burnet Road, Suite 4010 Austin, TX Type of Sponsor Priary Sponsor Details Akela Phara INC There is no secondary sponsor for this trial List of Countries of Principal Investigator Dr. Sukhdev Nayak of Site Site Phone/Fax/Eail AH Regional Cancer Centre Dr. Susha Bhatnagar AIIMS Unit of Anaestesiology,Ansari Nagar New Delhi DELHI Dr. Pushpalatha Gupta Dr. Bipin Patel Dr. R K Panday Dr. Saraswathi Devi Bhagwan Mahaveer Cancer Hospital and Research Centre Gujurat Cancer Research Institute, Jawaharlal Nehru Cancer Hospital. Kidwai Meorial Institute Of Oncology Dr.Kaalaksha Shenoy KMC Medical College Dept. of Anaesthesia,Pain Relief and Palitive care, suk_dev@rediffail.co Mangalabag Cuttack ORISSA Dept of Anaesthesia and Pain Palliative Care,JN Marg Jaipur RAJASTHAN Dept of Anaeshesia,,Civil Hospital Capus, Asarwa, Ahadabad GUJARAT Dept of Pain & Palliative Care,Idgah Hills, Bhopal MADHYA PRADESH Dept.of Anaesthesia and Pain Relief,Dr, M H Marigowda Road Bangalore KARNATAKA Dept. of Radiation Onco logy,,attavar Bangalore shuob@yahoo.co pushp_anil@yahoo.co drbipinbhaipatel@yaho o.co pandayrk59@rediffail. co saraswathidevi@sify.co shenoykrs@rediffail.c page 2 / 6

3 Details of Ethics Coittee Dr.Krishna Kuar Madurai Mission Hospital, KARNATAKA Dept of Radiation Oncology,,Lake Area,Melur Road, Madurai TAMIL NADU Dr.Nalini Kilara MS Raaih Hospital Dept of Medical Oncology,,MSR Nagar, MSRIT Post, Bangalore KARNATAKA Dr.Raghunadhrao Dr. Sachin Alel Niza Institute of Medical Science P.D Hinduja National Hospital Dept. of Medical Oncolo gy,,punjgutta Not Applicable N/A Dept. of Oncology, roo no.0106,old building,ground floor, MRC.Veer Savarkar Marg, Mahi Dr. Dinesh Singh Pentaed Hospital Dept of Oncology, 7 LSC Derawal Nagar,,Gujaranwala Town New Delhi DELHI Dr.Chetan Deshukh Ruby Hall Clinic 303,New Cancer Building,,40 Sassoon Road, Pune Dr.Shya Agarwal Sir Gangara Hospital Roo 212 A,Dept. of Medical Oncology,,Rajinder Nagar, New Delhi DELHI Dr. Mary Ann Muckaden TATA Meorial Hospital Dr. E. Borges Marg,Parel o drkskk@yahoo.co nalini_kilara@yahoo.co teleraa@rediffail.co svalel@yahoo.co drdinesh@hotail.co drchetandeshukh@ drshya_aggarwal@ya hoo.co uckaden@vsnl.net of Coittee Approval Status Date of Approval Is Independent Ethics Coittee? Ethics Coitte AH Regional Cancer Centre Ethics Coitte Bhagwan Mahaveer Cancer Hospital Gujrat Cancer Research Hospital Kidwai Meorial Subittted/Under Review Not Available page 3 / 6

4 Regulatory Clearance Status fro DCGI Health Condition / Probles Studied Intervention / Coparator Agent Inclusion Criteria Institute Madurai Mission Hospital MS Raaih Niza Institute of Medical Science Pentaid Hospital Sir Gangara Hospital Huan Ethics Coitte of TATA Meorial Hospital Institutional Ethics Coitte AIIMS Institutional Ethics Coitte Jawaharlal Nehru Cancer Hospital Institutional Ethics Coitte of Kusturba Medical College National Health and Education Society, Clinical Research and Ethics Coitte ( Hinduja Hospital) Poona Medical Research Foundation ( Ruby Hall Clinic) Status Approved/Obtained Health Type Subittted/Under Review Subittted/Under Review Not Available Not Available Date Condition Type Details Breakthrough Pain in Late stage cancer patients Intervention Fentanyl Taifun 100 cg and 200 cg Coparator Agent Age Fro Age To Gender Details Standard Breakthrough pain opioid treatent Inclusion Criteria "Inclusion Criteria : 1. Age 18 years or over. 2. A edically docuented diagnosis of cancer. 3. Use of a fixed around-the-clock dose of an opioid or a fixed cobination of opioids as aintenance therapy for pain relief with a dose equivalent of at least 60 g of oral orphine/day, or at least 25 µg of transderal fentanyl/hour, or at least 30 g of oxycodone daily or at least 8 g of oral hydroorphone daily. Current opioid treatent for at least 7 days prior to the randoization. 4. Current use of opioid edication for BTP. 5. At least 4 episodes of BTP per week with peak intensity of at least 4 on the nuerical pain scale (NPS) at pain onset. No ore page 4 / 6

5 Exclusion Criteria Method of Generating Rando Sequence Method of Concealent Blinding/Masking than 4 BTP episodes per day. (BTP is defined as a transitory increase in pain to greater than oderate intensity which occurs on a baseline pain of oderate intensity or less.) 6. The flow rate of inhalation of at least 20 L/in assessed by inspiratory flow eter(the highest of two readings will be used). 7. Karnofsky Perfoance Status 40 or better 8. Life expectancy of at least 12 weeks 9. Written infored consent Exclusion Criteria Details "Exclusion Criteria: 1. Uncontrolled or rapidly increasing BTP 2. Syptoatic intracranial tuors or cerebral etastases. 3. Persistent, syptoatic astha despite edication, as defined by daily syptos, frequent exacerbations, frequent nocturnal astha syptos, predicted FEV1 <60% or personal best PEFR < 60%. 4. Patients unable to use the inhaler (Based on Investigator?s opinion) 5. Inadequate lung function, as defined by PEFR < 60 % 6. Hypersensitivities, allergies or contraindications to fentanyl or study edication coponents 7. A recent history of alcohol or substance abuse (in the past 1 year). 8. Radiotherapy to the thorax within 30 days of the beginning of the titration phase. 9. Cognitive ipairent or any neurological or psychiatric disease which could coproise the ability of the patient to coplete the assessents. 10. Participation in any clinical study with experiental drug within 30 days of the randoization, except participation in prior Fentanyl TAIFUN studies. 11. Any clinical condition (e.g. severe hepatic ipairent) or edical history which, in the opinion of the investigator would not allow for the safe copletion of the study or the safe adinistration of the study drug (e.g. elderly or cachectic patient on the lowest dose of aintenance opioid therapy). 12. Pre-enopausal woen (last enstruation < 1 year prior to the screening visit) who:? are not surgically sterile and/or? have a positive pregnancy test at baseline visit and/or? are of childbearing potential and are not practicing an acceptable eans of birth control or do not plan to continue using this ethod throughout the study and/or are nursing Stratified block randoization Centralized Open Label Priary Outcoe Outcoe Tiepoints Safety Paraeters (Vital Signs, pulse Oxyetry, Spiroetry, ECG, PEFR, PIFR, laboratory paraeters etc.) 4 hours in titration period iediately after drug adinistration. The patient will be onitored for safety paraeters for 28 days in total. Secondary Outcoe Outcoe Tiepoints Target Saple Size Phase of Trial Phase 3 Date of First Enrollent () Date of First Enrollent (Global) Estiated Duration of Trial Recruitent Status of Efficacy (Nuerical pain Score) Total Saple Size=500 Saple Size fro = 01/10/2009 Years=1 Months=6 Days=0 Not Yet Recruiting T=30 inutes page 5 / 6

6 Powered by TCPDF ( REFCTRI/2009/ Trial (Global) Recruitent Status of Trial () Publication Details Brief Suary This is a ulticenter, ultinational, randoized, open label, parallel group trial to evaluate the safety of Fentanyl TAIFUN treatent after titrated dose adinistration and the current breakthrough pain treatent for breakthrrough pain in cancer patients on aintenance opioid therapy. the duration of the study fro first dose adinistration is 28 days. The study plans to enrol 500 patients globally of which we plan to enrol 200 patients in. The titration period will last fro 3 days to 21 days. The observation period ay last fro 7 days to 21 days.the priary outcoe eaures will be safety variables. Patients will be randoized to receive either the investiogational drug or the current breakthrough pain treatent (opioid) at the start of titration in the ratio of 4:1. In we plan to enrol 200 Patients for the study page 6 / 6