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CTRI Number  CTRI/2009/091/000243 [Registered on: 30/06/2009]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A multicentre, multinational, randomizedm Double-Blind, Placebo Controlled, crossover trial to evaluate efficacy and safety of Fentanyl TAIFUN ® treatment after titrated dose administration for breakthrough pain in cancer patients on maintenance opioid therapy 
Scientific Title of Study   A multicentre, multinational, randomizedm Double-Blind, Placebo Controlled, crossover trial to evaluate efficacy and safety of Fentanyl TAIFUN ® treatment after titrated dose administration for breakthrough pain in cancer patients on maintenance opioid therapy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CL_700_015_PRO  Protocol Number 
EUDRA CT No. 2007-005393-31   EudraCT 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Dilip Pawar  
Designation   
Affiliation   
Address  Akela Clinical Research Pvt Ltd
202, Wellington business park, Marol Naka, Andheri- Kurla Road, Andheri ( East)
Mumbai
MAHARASHTRA
400059
India 
Phone  + 91 22 40551111  
Fax  + 91 22 40551115  
Email  dpawar@akelapharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Dilip Pawar  
Designation   
Affiliation   
Address  Akela Clinical Research Pvt Ltd
202, Wellington business park, Marol Naka, Andheri- Kurla Road, Andheri ( East)
Mumbai
MAHARASHTRA
400059
India 
Phone  + 91 22 40551111  
Fax  + 91 22 40551115  
Email  dpawar@akelapharma.com  
 
Details of Contact Person
Public Query  
Name  Dr. Dilip Pawar  
Designation   
Affiliation   
Address  Akela Clinical Research Pvt Ltd
202, Wellington business park, Marol Naka, Andheri- Kurla Road, Andheri ( East)
Mumbai
MAHARASHTRA
400059
India 
Phone  + 91 22 40551111  
Fax  + 91 22 40551115  
Email  dpawar@akelapharma.com  
 
Source of Monetary or Material Support  
Akela Pharma INC 11400 Burnet road, Suite 4010 Austin, TX 78758 
 
Primary Sponsor  
Name  Akela Pharma INC 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. M. S Vishveshwara  Bharat Hospital  Number 438, ,Hebbal Area,-570017
Mysore
KARNATAKA 		 + 0821 428004/22
+ 91 821 4280284
clinicalresearchbhio@gmail.com 
Dr. Raj Nagarkar  Curie Manavata Cancer Centre  Opp Mahamarg Bus Stand,,Mumbai Naka,-422004
Nashik
MAHARASHTRA 		 ( 91253) 2592666
0253 6611243/ 0253 2592666
drrajnagarkar@yahoo.co.in 
Dr. Kamble  Government Medical College,  Government Medical College,,-440003
Nagpur
MAHARASHTRA 		 + 91 712 2745209
+ 91 712 2745209
drkmkamble@yahoo.co.in 
Dr. Madhuri Lokapur  Jehangir Clinical Development Centre  32 Sassoon Road,,Jehangir Hospital Premises,-411001
Pune
MAHARASHTRA 		 + 91 20 26059318
+ 91 20 26059319
madhulok@yahoo.com 
Dr. Tapan Saikia  Prince Aly Khan Hospital  Aga hall, Nesbit Road,,Mazgoan,-400010
Mumbai
MAHARASHTRA 		 + 91 22 23777919
+ 91 22 23743820
tapan.saikia@gmail.com 
Dr. A Ranade  Sanjeevan Hospital  Plot no 23, off Karve road,,Erandawne,-411004
Pune
MAHARASHTRA 		 + 91 20 24477333
+ 91 20 66093259
draaranade@yahoo.com 
Dr. Shailesh Bondarde  Shatabdi Hospital  Suyojit City centre,Opp mahamarg bus stand,-422005
Nashik
MAHARASHTRA 		 ( 91253)2501888
0253 2501888
shaileshbondarde@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Clinicom   Approved 
Government Medical College Ethics Committe  Approved 
HCG Central Ethics Committe  Approved 
Jehangir Clinical Development Centre Ethics Committe   Approved 
Prince Aly Khan Hospital Committe  Submittted/Under Review 
Sanjeevan Hospital Ethics Committe  Approved 
Shatabdi Hospital Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Breakthrough Pain in late stage cancer patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fentanyl Taifun  100 mcg and 200 mcg 
Comparator Agent  Placebo  100 mcg and 200 mcg 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  "Inclusion Criteria : 1. Age 18 years or over. 2. A medically documented diagnosis of cancer. 3. Use of a fixed around-the-clock dose of an opioid or a fixed combination of opioids as maintenance therapy for pain relief with a dose equivalent of at least 60 mg of oral morphine/day, or at least 25 µg of transdermal fentanyl/hour, or at least 30 mg of oxycodone daily or at least 8 mg of oral hydromorphone daily. 4. Current opioid treatment for at least 7 days prior to the randomization. 5. Current use of opioid medication for BTP. 6. At least one BTP episode per Day with peak intensity of at least 4 on the numerical pain scale (NPS) at pain onset. No more than 4 BTP episodes per day. BTP is defined as a transitory increase in pain to greater than moderate intensity which occurs on a baseline pain of moderate intensity or less. 7. The flow rate of inhalation of at least 20 L/min assessed by inspiratory flow meter (the highest of two readings will be used). 8. Written informed consent 
 
ExclusionCriteria 
Details  "Exclusion Criteria: 1. Uncontrolled or rapidly increasing BTP 2. Symptomatic intracranial tumors or cerebral metastases. 3. Persistent, symptomatic asthma despite medication, as defined by daily symptoms, frequent exacerbations, frequent nocturnal asthma symptoms, 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 medication components 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 impairment or any neurological or psychiatric disease which could compromise the ability of the patient to complete the assessments. 10. Participation in any clinical study with experimental drug within 30 days of the randomization, except participation in prior Fentanyl TAIFUN® studies. 11. 11.Any clinical condition [e.g. severe hepatic impairment defined by: (1) serum total bilirubin higher than 3 x upper limit of normal (ULN) and/or, (2) serum alanine aminotransferase and serum aspartate aminotransferase higher than 10 x ULN, (3) serum albumin lower than 28 g/L in conjunction with either (1) or (2)], or medical history which, in the opinion of the investigator would not allow for the safe completion of the study or the safe administration of the study drug (e.g. elderly or cachectic patient on the lowest dose of maintenance opioid therapy). 12. Pre-menopausal women (last menstruation < 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 means of birth control or do not plan to continue using this method throughout the study and/or are nursing 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Efficacy parameters ( numerical Pain Scale )  T = 15minutes , T = 60minutes  
 
Secondary Outcome  
Outcome  TimePoints 
Safety parameters ( Vital Signs, Pulse oxymeter, Spirometry, ECG, PEFR, PIFR, Laboratory Parameters )   4 Hours in titration period immediately after drug administration. The patient will be monitored for safety parameters for 28 days 
 
Target Sample Size   Total Sample Size="180"
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" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/08/2009 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   A multicentre, multinational, randomizedm Double-Blind, Placebo Controlled, crossover trial to evaluate efficacy and safety of Fentanyl TAIFUN ® treatment after titrated dose administration for breakthrough pain in cancer patients on maintenance opioid therapy Study plans to enroll 180 patients and randomize 135 patients to cross over observation period so as to get 120 patients to complete the study.Of the 9 BTP episodes to be evaluated in Double Blind Observation period 6 episodes will be evaluated with IP and 3 Episodes will be evaluated withPlacebo. The Randomization will be done in blocks of 3 episodes in such a way that patient does not receive placebo twice in a row. Efficacy will be evaluted based on NPS score. 
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