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CTRI Number  CTRI/2010/091/001415 [Registered on: 24/11/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of Desmopressin Intranasal Solution BP (Mfd. by Biodeal Laboratories Pvt. Ltd.) Vs. Desmopressin Intranasal Solution BP (Mfd. by Ferring Pharmaceuticals Ltd.) in patients diagnosed with Central Cranial Diabetes Insipidus. 
Scientific Title of Study   A Prospective, Comparative, Randomized, Double Blind, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Desmopressin Intranasal Solution BP (Mfd. by Biodeal Laboratories Pvt. Ltd.) Vs. Desmopressin Intranasal Solution BP (Mfd. by Ferring Pharmaceuticals Ltd.) in patients diagnosed with Central Cranial Diabetes Insipidus. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT/SC/02/2010 & Version No: 1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. M.Pavan Kumar 
Designation   
Affiliation   
Address  K.K.Hospital
No.9, A-1/A-2, A Sector, Yelahanka New Town
Bangalore
KARNATAKA
560 064
India 
Phone  28462189  
Fax  28460063  
Email  pavankdr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Hitesh Koradia 
Designation   
Affiliation   
Address  Biodeal Laboratories Pvt. Ltd
508, G.I.D.C Estate
Not Applicable
N/A
363035
India 
Phone  02752243730  
Fax  02752243733  
Email  hiteshkoradia@biodealindia.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Hitesh Koradia 
Designation   
Affiliation   
Address  Biodeal Laboratories Pvt. Ltd
508, G.I.D.C Estate
Not Applicable
N/A
363035
India 
Phone  02752243730  
Fax  02752243733  
Email  hiteshkoradia@biodealindia.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Biodeal Laboratories Pvt. Ltd 508, G.I.D.C Estate, Wadhwan city, Dist Surendranagar,Gujarat - 363035 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
10. Dr. Jagannath B  Deeksha Hospital  #387/347, B.B.Road,Nehrunagar, Yelahanka Old Town-560064
Bangalore
KARNATAKA 
080 - 28561228, 8105161033

jagannathb78@yahoo.com 
2. Dr. Ramesh K.N  Fortis Hospitals  111, West of Chord Road,Opp Rajajinagar, 1st Block Junction-560 086
Bangalore
KARNATAKA 
91 - 80 - 23004444
91-80-23004242
physicianramesh@rediffmail.com 
1. Dr.M.Pavan Kumar  K.K.Hospital  No.9, A-1/A-2,'A' Sector Yelahanka New Town-560064
Bangalore
KARNATAKA 
28462189, 28461933
28460063
pavankdr@gmail.com 
6. Dr. I.Periyandavar  Lifeline Diabetes Centre  54/9A, Lattice Bridge Road,1st floor, Mosque Complex, Adyar-600020
Chennai
TAMIL NADU 
65372767, 24900550

meku67@yahoo.co.in 
3. Dr. Sunil H.S  M.S.Ramaiah Hospital  No. 256, Basement Floor,I Cross, Ganganagar-560 032
Bangalore
KARNATAKA 
23330968, 9886198506

sunilhirenappa@yahoo.com 
8. Dr. G.S.Varadaraj  Raajah Hospital  60, Gandhi Street,B.R.Puram-641004
Coimbatore
TAMIL NADU 
2571297, 2592997

drvaradan5@rediffmail.com 
4. Dr. Ravi Kumar  Rajmahal Vilas Hospital  #138,Sanjaynagar-560 094
Bangalore
KARNATAKA 
9880848262, 080 42664366, 23412708
23416332
drravirmv@gmail.com 
5. Dr. S.Chandrasekharan  Sooriya Hospital  1. Arunachalam Road,Sallgramam-600 093
Chennai
TAMIL NADU 
23761751, 23761752, 23761753

 
9. Dr. M.S.Mylswamy  Sumith Hospital  Balan Nagar,Peelamedu-641004
Coimbatore
TAMIL NADU 
2573578, 2591184

msmylswamy@yahoo.com 
7. Dr. Asha Govindraj  V - Care Hospital  No. 29, 1st Main Road,A1st Block, R.T.Nagar-560032
Bangalore
KARNATAKA 
32511091, 23434373, 23434374

govindrajasha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
1. Rajmahal Vilas Hospital  Approved 
10. Deeksha Hospital  Approved 
2. Fortis Hospital  Approved 
3. Rajmahal Vilas Hospital  Approved 
4. Rajmahal Vilas Hospital  Approved 
5. Sooriya Hospital  Approved 
6. Lifeline Diabetes Centre  Approved 
7. V-Care Hospital  Approved 
8. Raajah hospitals  Approved 
9. Sumith Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  In this study we will be enrolling cases with Central Cranial Diabetes Insipidus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Desmopressin Intranasal Solution BP  0.1 to 0.4 mL daily [10 to 40 micrograms (mcg)], either as a single dose or divided into two or three doses a day.  
Comparator Agent  Intranasal Solution BP  0.1 to 0.4 mL daily [10 to 40 micrograms (mcg)], either as a single dose or divided into two or three doses a day.  
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1)Male and Females aged 18 years and over. 2)Patients diagnosed with Central Cranial Diabetes Insipidus with any cause. 3)No clinically significant abnormal findings in the medical history, physical exam or nasal exam. 4)Patients must give written informed consent after reading the Patient Information and Consent Form and having had the opportunity to discuss the study with the Investigator. 5)Patient willing to follow up and comply with the Protocol requirements.  
 
ExclusionCriteria 
Details  1)Patients with other forms of Diabetes Insipidus and Diabetes Mellitus. 2)Patient not willing to participate in the trial or not in position to give the informed consent. 3)Pregnant or lactating females. 4)Participation in any other clinical trial involving investigational products within 30 days of screening. 5)Individuals with known hypersensitivity to desmopressin acetate or to any of the components of DDAVP Intranasal Solution. 6)Patients with moderate to severe renal impairment (defined as a Creatinine clearance below 50ml/min). 7)Patients with hyponatremia or a history of hyponatremia. 8)Patients with medical history, especially: high blood pressure, breathing problems, nasal congestion, heart disease, fluid or vitamin/mineral (electrolyte) imbalances, any drug allergies. 9)Patients using substances which are known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine and carbamazepine, may cause an additive antidiuretic effect leading to an increased risk of water retention and/or hyponatraemia. NSAIDs may induce water retention and/or hyponatraemia.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To calculate and compare the reduction in mean symptoms (Polyuria, Polydipsia and Nocturia) among patients between the two groups.  At Baseline (Day 1), Week 2, Week 4, Week 8 and Week 12  
 
Secondary Outcome  
Outcome  TimePoints 
?To assess Global evaluation of efficacy and tolerability between two groups at the end of treatment. ?To analyze the rate and incidence of adverse events among patients between the two groups.   At Baseline (Day 1), Week 2, Week 4, Week 8 and Week 12  
 
Target Sample Size   Total Sample Size="62"
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 4 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/10/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
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   the study is a A Prospective, Comparative, Randomized, Double blind, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Desmopressin Intranasal Solution BP (Mfd. by Biodeal Laboratories Pvt. Ltd.) Vs. Desmopressin Intranasal Solution BP (Mfd. by Ferring Pharmaceuticals Ltd.) in patients diagnosed with Central Cranial Diabetes Insipidus for 12 weeks in 62 patients that will be conducted in eight centers in India. The primary outcome measures will be to calculate and compare the reduction in mean symptoms (Polyuria, Polydipsia and Nocturia) among patients between the two groups. The Secondary outcome measures will be to assess Global evaluation of efficacy and tolerability between two groups at the end of treatment and to analyze the rate and incidence of adverse events among patients between the two groups.  
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