| CTRI Number |
CTRI/2010/091/001177 [Registered on: 14/09/2010] |
| Last Modified On: |
15/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Safety and Efficacy Study in Primary Insomnia Patients-Study B |
Scientific Title of Study
Modification(s)
|
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK4305 in Patients With Primary Insomnia- Study B |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MK-4305-029-00 |
Protocol Number |
| NCT01097629 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrMonishaSharma |
| Designation |
Director Clinical Research India |
| Affiliation |
MSD Pharmaceuticals Pvt Ltd |
| Address |
6th Floor, Vatika Towers - B, Golf Course Road Sector 54, Gurgaon HARYANA 122002 India
Gurgaon
HARYANA
122002
India |
| Phone |
01244647300 |
| Fax |
01244375561 |
| Email |
monisha_sharma@merck.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
DrMonisha Sharma |
| Designation |
Director Clinical Research India |
| Affiliation |
MSD Pharmaceuticals Pvt Ltd |
| Address |
6th Floor, Vatika Towers - B, Golf Course Road Sector 54, Gurgaon HARYANA 122002 India
Gurgaon
HARYANA
122002
India |
| Phone |
01244647300 |
| Fax |
01244375561 |
| Email |
monisha_sharma@merck.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Merck & Co Inc,
One Merck Drive P O Box 100 Whitehouse Station, NJ, 08889-0100 USA |
|
Primary Sponsor
Modification(s)
|
| Name |
Merck Co Inc |
| Address |
One Merck Drive P O Box Whitehouse Station NJ USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
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Countries of Recruitment
Modification(s)
|
India
Australia
Brazil
Canada
Denmark
Finland
France
Germany
Italy
Mexico
Peru
Poland
Republic of Korea
Russian Federation
South Africa
Spain
Sweden
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Ramanand Satapathy |
Brain Mind Behaviour Neurosciences & Research Institute |
201, MVV Chambers,,Opp King George Hospital,-530002
Visakhapatnam
ANDHRA PRADESH |
+91 98482 12220
+91 891 2713686
drramanand@yahoo.co.in |
| Dr Shiv Gautam |
Gautam Hospital & Research Centre [M] |
1, Jacob Road Civil lines 302006
Jaipur
RAJASTHAN |
1412222333
1412222630
dr_shivgautam@yahoo.com |
| Dr Ramanathan Sathianathan |
Madras Medical College & Government Genral Hospital |
Poonamalle High Road,-600003
Chennai
TAMIL NADU |
+91 9841019910
+91 44 25388989
sathianathen6@yahoo.com |
| Dr Rangashetty Srinivasa |
MS Ramaiah Medical College & Hospital |
MS Ramaiah Nagar,New Bel Road, -560 054
Bangalore
KARNATAKA |
+91 80 22183126
+91 80 40528402
drrsrinivasa@hotmail.com |
| Dr Jagadisha Thirthalli |
National institute of mental Health and Neurosciences |
Hosur Road,-560029
Bangalore
KARNATAKA |
+91 9845261731
+91 80 26576465
jagatth@yahoo.com |
| Dr Mahesh Gowda |
Spandan Nursing Home |
456/46, 6th Main,5th Block, Rajaji Nagar-
Bangalore
KARNATAKA |
+91 9845134915
+91 80 23141028
maheshrgowda@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Arogyam Ethics Committee |
Approved |
| Ethical Review Board, |
Approved |
| Institutional ethics committee, King George Hospital |
Approved |
| Spandana Ethics Committee |
Approved |
| The Ethics Committee, |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition, Primary Insomnia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
MK4305 High dose |
MK4305 40 mg plus matching PBO for patients less than 65 years old MK4305 30 mg plus matching PBO for patients equal or more than 65 years old. |
| Intervention |
MK4305 Low dose |
MK4305 20 mg + matching PBO for patients < 65 years old; MK4305 15 mg + matching PBO for patients >= 65 years old. |
| Comparator Agent |
Placebo Comparator |
Matching placebo to MK4305 doses |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Must be more than 18 yrs old on the day of signing informed consent
Diagnosed with Primary Insomnia
Patient is in good physical and mental health
Patient more than and equal 65 yrs old score at least 25 on the Mini Mental State Exam
A female patient who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception
Patient reports difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria)
Patient reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1
The patients regular bedtime is between 9 pm-1 am
Patient is willing to refrain from napping while in study
Patient is able to read, understand and complete questionnaires and all diaries
Patient is willing to limit alcohol, caffeine, and nicotine consumption while in the study
For a portion of patients: Patient must be willing to stay overnight in a sleep laboratory and must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory |
|
| ExclusionCriteria |
| Details |
Female patient is pregnant and or breastfeeding at Prestudy visit, or expecting to conceive while in study
History or diagnosis of another sleep disorder
Difficulty sleeping due to a medical condition
History of a neurological disorder
History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication
Ongoing depression
History of substance abuse or dependence
History or current evidence of a clinically significant cardiovascular disorder or clinically significant ECG at Prestudy Visit
Patient taking certain prohibited medications
Patient consumes the equivalent of more than 15 cigarettes a day
Patient has a history of malignancy less or equal 5 years prior to signing informed consent, with the exception of basal cell or squamous cell skin cancer if adequately treated
Patient is considered morbidly obese
Patient was previously randomized in another investigational study of MK4305
|
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Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| MK4305 high dose versus placebo: Change from baseline in latency to onset of persistent sleep |
Month 1 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| MK4305 high dose versus placebo: Change from baseline in subjective total sleep time |
Week 1 |
| MK4305 high dose versus placebo: Change from baseline in wake time after persistent sleep onset |
Night 1 |
| MK4305 high dose versus placebo: Change from baseline in subjective time to sleep onset |
Week 1 |
| MK4305 high dose versus placebo: Change from baseline in latency to onset of persistent sleep |
Night 1 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="945"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
05/05/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="6"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NAP |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a multicenter study to test the hypothesis that MK4305 compared to placebo measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. Globally 945 patients would be randomized in this trial. India would contribute up to 70 patients in this trial. Globally first patient was enrolled on 05 May 2010. At India, first patient screening is targated on 29 September 2010. Enrollment status: (globally) 1,019 patients and 27 patients (India) |