| CTRI Number |
CTRI/2024/07/071200 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Observational study to evaluate safety and effectiveness of approved combination of medicines in participants with Insomnia & Sleep Disorder. |
|
Scientific Title of Study
|
A Prospective, Multicenter, Open labeled, Randomized, phase IV clinical study to evaluate safety and efficacy of 2 FDCs of Zolpidem Tartrate IP 5 mg / 10 mg plus Melatonin 3 mg film coated tablets in subjects with Primary Insomnia and Sleep Disorder. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CE-CT-ZM-2021 version 3.0 dated 11 Mar 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vipul Mishra |
| Designation |
Head of the department, Critical care, Pulmonology & Sleep Medicine |
| Affiliation |
Pushpanjali Hospital and Research center |
| Address |
Department of Sleep Medicine, Pushpanjali palace, Delhi gate. Agra-282002. Uttar Pradesh
NIL
Agra
UTTAR PRADESH
282002
India |
| Phone |
9811190105 |
| Fax |
|
| Email |
vpcare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Phadke |
| Designation |
Consultant Medical Manager |
| Affiliation |
Linux Laboratories Private Limited |
| Address |
492 Pallavaram-Thuraipakkam Rd., S. Kolathur, Viduthalai Nagar Extension, Kovilambakkam, Chennai, Tamil Nadu 600117, INDIA.
NIL
Chennai
TAMIL NADU
600117
India |
| Phone |
9821048838 |
| Fax |
|
| Email |
neha23p@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Kumar |
| Designation |
CEO |
| Affiliation |
CliniExperts Research Services Pvt. Ltd. |
| Address |
Unit No. 324-325, City Centre Mall, Plot No. 5, Pocket 8, Block B, Sector 12 Dwarka, Dwarka, New Delhi, Delhi, 110075
NIL
New Delhi
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
|
Source of Monetary or Material Support
|
| Linux Life Sciences Pvt Ltd,
R.S NO.241 1 and 241 5, Kalitheerthal Kuppam, Madagadipet Post, Puducherry, 605107, India. |
|
|
Primary Sponsor
|
| Name |
Linux Laboratories Private Limited |
| Address |
#492 Pallavaram-Thuraipakkam Rd., S. Kolathur Viduthalai Nagar Extension, Kovilambakkam, Chennai, Tamil Nadu 600117, INDIA. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Fenil Shah |
Aatman Hospital |
Ground floor, psychiatry department, 5,anreshanRao House opp. Umiya Mata Mandir bopalghuma main road bopal Amhedabad 380058, Gujrat
Ahmadabad
GUJARAT |
9157376800
drfenil.cr@gmail.com |
| Dr Asish Mukhopadhyay |
Nil Ratan Sarkar Medical College and Hospital |
3 rd floor, department of Psychiatry, Nil Ratan Sarkar Medical College and Hospital, 138, Acharya Jagdish Chandra Bose Rd, Sealdah, Raja Bazar, Kolkata, West Bengal 700014, India
Kolkata
WEST BENGAL |
8250737511
asish47@gmail.com |
| Dr Vipul Mishra |
Pushpanjali Hospital and Research Center |
Department of Sleep Medicine, Pushpanjali palace, Delhi gate. Agra-282002. Uttar Pradesh
Agra
UTTAR PRADESH |
9811190105
vpcare@gmail.com |
| Dr Konatham Rambabu |
Visakha Institute of medical science |
Room No. 1, 2nd floor, Department of general medicine Hanumanthawaka, Chinnagadhilli, Visakhapatnam 530040. Andhrapradesh
Visakhapatnam
ANDHRA PRADESH |
7075852341
drkrambaburesearch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee, NRS Medical College |
Approved |
| Institutional Ethics Committee Aatman Hospital |
Approved |
| Pushpanjali Hospital Ethics Committee |
Approved |
| VISAKHA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Zolpidem Tartrate IP 10 mg with Melatonin 3 mg |
Dose: Zolpidem Tartrate IP 10 mg with Melatonin 3 mg
Frequency: Once a day for 28 days
Route of administration: Oral |
| Intervention |
Zolpidem Tartrate IP 5 mg with Melatonin 3 mg |
Dose: Zolpidem Tartrate IP 5 mg with Melatonin 3 mg
Frequency: Once a day for 28 days
Route of administration: Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Signed informed consent prior to any study mandated procedure.
2. Women of childbearing potential must have negative pregnancy tests and use
reliable methods of contraception up to 30 days after EOT.
3. Body mass index between 18.5 to 32.0 kg per m2.
4. Insomnia disorder according to DSM 5 criteria.
5. Insomnia Severity Index score equal or grater than 15. |
|
| ExclusionCriteria |
| Details |
1. Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement behavior disorder, or narcolepsy.
2. Self-reported usual daytime napping greater than equal to 1 hour per day, and greater than equal to 3 days per week.
3. Caffeine consumption greater than equal to 600 mg per day.
4. Shift work within 2 weeks prior to the screening visit, or planned shift work during study.
5. Travel greater than equal to 3 time zones within 1 week prior to the screening visit, or planned travel greater than equal to 3 time zones during study.
6. Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator.
7. AST and, or ALT greater than 2 times ULN and, or direct bilirubin greater than 1.5 times ULN. Except for the known history of Gilberts syndrome.
8. Severe renal impairment Which is known or defined as estimated creatinine clearance less than 30 mL per min).
9. History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
10. Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject full participation in the study or compliance with the protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and tolerability of 2 FDCs of Zolpidem Tartrate IP 5 mg and Melatonin 3 mg with Zolpidem Tartrate IP 10 mg and Melatonin 3 mg film coated tablets in subjects with Primary Insomnia & Sleep Disorder. |
Day1, Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of 2 FDCs of Zolpidem Tartrate IP 5 mg and Melatonin 3 mg with Zolpidem Tartrate IP 10 mg and Melatonin 3 mg film coated tablets in subjects with Primary Insomnia & Sleep Disorder. |
Day 1, Day 14, Day 28 |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This phase IV clinical trial is a
prospective, multicenter, open-label, randomized study aimed at evaluating the
safety and efficacy of two fixed-dose combinations (FDCs) in treating subjects
with primary insomnia and sleep disorders. Spanning 4 weeks more or less 2 Days,
the trial will involve 220 male and female participants aged 18-65, selected
based on specific inclusion and exclusion criteria across four sites. The
primary objective is to assess the safety and tolerability of the FDCs, with
endpoints including Clinical Global Impression-change, average sleep latency,
and adverse events, evaluated at baseline, Day 14, and Day 28. The secondary
objective focuses on the efficacy of the FDCs, measured by changes in the
Insomnia Severity Index at the same time intervals. Participants are required
to take one tablet orally each night for 28 days. The trial procedure involves
an initial baseline visit for informed consent, demographic data collection,
medical history review, and initial assessments, followed by subsequent visits
at two-week intervals for ongoing evaluations, diary reviews, and compliance
checks. Emphasis is placed on contraception for female participants and
rigorous monitoring to ensure the integrity of the study and the safety of the
subjects throughout the trial.
|