| CTRI Number |
CTRI/2010/091/001415 [Registered on: 24/11/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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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. |
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Scientific Title of Study
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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 |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| CT/SC/02/2010 & Version No: 1.0 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr. M.Pavan Kumar |
| Designation |
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| Affiliation |
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| 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 |
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Details of Contact Person
Scientific Query
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| Name |
Dr. Hitesh Koradia |
| Designation |
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| Affiliation |
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| 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 |
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Details of Contact Person
Public Query
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| Name |
Dr. Hitesh Koradia |
| Designation |
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| Affiliation |
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| 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 |
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Source of Monetary or Material Support
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Primary Sponsor
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| Name |
Biodeal Laboratories Pvt. Ltd 508, G.I.D.C Estate, Wadhwan city, Dist Surendranagar,Gujarat - 363035 |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| 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
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| 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 |
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Details of Ethics Committee
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| 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 |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
In this study we will be enrolling cases with Central Cranial Diabetes Insipidus, |
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Intervention / Comparator Agent
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| 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. |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| 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.
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| 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.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| 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 |
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Secondary Outcome
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| 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.
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At Baseline (Day 1), Week 2, Week 4, Week 8 and Week 12 |
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Target Sample Size
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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" |
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Phase of Trial
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Phase 4 |
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Date of First Enrollment (India)
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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 |
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Estimated Duration of Trial
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Years="0"
Months="8"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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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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