| CTRI Number |
CTRI/2011/091/000026 [Registered on: 31/01/2011] |
| Last Modified On: |
26/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Etizolam CR 1.5 mg Tablet in comparison with Etizolam 0.5 mg Tablet in Subjects with Chronic Anxiety and Insomnia |
|
Scientific Title of Study
|
?A Comparative, Randomized, Open-label, and Multi-Center Clinical Phase III Trial to Investigate the Safety and Efficacy of Etizolam CR 1.5 mg Tablet in comparison with Etizolam 0.5 mg Tablet in Subjects with Chronic Anxiety and Insomnia." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PRECISE/ETIZOLAM/CT/1109A |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Kavan P. Lakdawala |
| Designation |
|
| Affiliation |
|
| Address |
Cinic, Opera House, Mumbai
Mumbai
MAHARASHTRA
India |
| Phone |
|
| Fax |
|
| Email |
Drkavan@Indiatimes.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kavan P. Lakdawala |
| Designation |
|
| Affiliation |
|
| Address |
Cinic, Opera House, Mumbai
Mumbai
MAHARASHTRA
India |
| Phone |
|
| Fax |
|
| Email |
Drkavan@Indiatimes.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kavan P. Lakdawala |
| Designation |
|
| Affiliation |
|
| Address |
Cinic, Opera House, Mumbai
Mumbai
MAHARASHTRA
India |
| Phone |
|
| Fax |
|
| Email |
Drkavan@Indiatimes.com |
|
|
Source of Monetary or Material Support
|
| Precise Biopharma Pvt. Ltd.,
209, Jhalwar,Patanwala Ind. Estate, LBS Marg.,
Ghatkopar (W), Mumbai |
|
Primary Sponsor
Modification(s)
|
| Name |
Precise Biopharma Pvt Ltd |
| Address |
209, Jhalawar,
Patanwala Ind. Estate
L B S Marg.,Ghatkopar west
Mumbai-400086
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Kavan P Lakdawala |
Cinic, Opera House, Mumbai,Drkavan@Indiatimes.com |
,-
Mumbai
MAHARASHTRA |
Drkavan@Indiatimes.com |
| Dr. Ketan Parmar |
Clinic, Borivali (E), Mumbai, Thousand_Minds@Hotmail.com |
,-
Mumbai
MAHARASHTRA |
Thousand_Minds@Hotmail.com |
| Dr. P.M.Chougule |
Swastik Hospital, Kolhapur, kpr_paris@sancharnet.in |
,-
Kolhapur
MAHARASHTRA |
kpr_paris@sancharnet.in |
| Dr. N.H. Patel |
Upkar Hospital, Himatnagar, drnhpatelupkar@yahoo.co.in |
,-
|
drnhpatelupkar@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Chronic Anxiety and Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Etizolam |
0.5mg |
| Intervention |
Etizolam CR 1.5mg |
1.5 mg |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
■ All patients with duly filled and signed in ICFs [Informed Consent Forms]
■ Ages: > 18 years and < 65 years
■ Genders Eligible for Study: both
■ Confirmed diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual for Mental Disorders-IV [DSM-IV-TR]) present at the time of evaluation for at least 3 months
■ Subjects will be eligible to continue in the double-blind treatment phase if they have a mean LPS ≥20 minutes on the 2 nights of PSG monitoring, with an LPS of no less than 15 minutes on either night
|
|
| ExclusionCriteria |
| Details |
■ Patients unwilling to sign on ICF
■ Patients having participated in any previous studies of Etizolam, or having taken any other investigational drug within 30 days,
■ Patients having sleep schedule changes associated with shift work
■ Medications or supplements known to affect sleep-wake function must not have been taken within 5 days or 5 half-lives of the start of the study.
■ Patients with a history of sleep apnea, chronic obstructive pulmonary disease, seizures, anxiety, depression, schizophrenia, bipolar disorder, mental retardation, a cognitive disorder,
■ Patients with history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic diseases (unless controlled with protocol-allowed medications)
■ Patients with history of drug addiction or abuse within 12 months of the study.
■ At screening, if patients have an apnea-hypopnea index >10 or a periodic leg movement arousal index >10.
■ Active malignant disease or current cytostatic treatment
■ Known severe renal insufficiency
■ Liver disease expected to have any potential impact on survival, or elevated A ST or ALT > 2x upper limit of normal
■ Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months
■ Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practicing or do not plan to continue practicing acceptable methods of birth control
■ Patients with a history of chronic hepatitis B or C infection, HIV infection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ? Change in mean latency in persistent sleep [LPS] measured by polysomnography (PSG) recording in the hospital between day 0 and day 7. |
day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To be assessed by polysomnography to record change between day 0 and day 7.
? Total Sleep Time [TST]
? Sleep Efficiency.
? Wake Time after Persistent Sleep Onset.
? Number of Awakenings after Persistent Sleep.
To be assessed by subject sleep diary and sleep questionnaire
? Subjective Sleep Latency.
? Subjective Total Sleep
? Subjective Sleep Quality.
? Subjective Wake Time after Sleep Onset.
? Subjective Number of Awakenings.
? Subjective Ease of Falling Back to Sleep after Awakening.
? Stage 1 Nonrapid Eye Movement (NREM) Sleep
? Stage 2 Nonrapid Eye Movement (NREM) Sleep
? Stage 3/4 Nonrapid Eye Movement (NREM) Sleep
? Latency to Rapid Eye Movement (REM) Sleep
? Percentage of Total Sleep Time in REM Sleep
|
day 7 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/12/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is A Comparative, Randomized, Open-label, and Multi-Center Clinical Phase III Trial to Investigate the Safety and Efficacy of Etizolam CR 1.5 mg Tablet in comparison with Etizolam 0.5 mg Tablet in Subjects with Chronic Anxiety and Insomnia that will be conducted in four centres in India. |