Health Condition 1: null- Primary Insomnia in adult & elderly patients
Conditions
Interventions
Intervention1: IN-AQUL-001: Start as one tablet at night and if required escalate to two tablets at first follow-up visit. (30 minutes before lying down to sleep for a period of 2 weeks of treatment).
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients with: 1)Either sex 18 to 75 years of age 2)Primary insomnia as defined by the DSM-IV for at least 1 month. 3)Mean subjective 1) LSO ≥ 20 minutes; 2) WASO ≥ 60 minutes; 3) TST ≤ 390 minutes, based on sleep diary recorded during placebo run-in period 4)Female patients of childbearing potential: nonpregnant, nonlactating, with negative serum pregnancy test at screening and willing to utilize an acceptable method of contraception throughout the study period. 5)Willing to provide written informed consent
Exclusion criteria
Exclusion criteria: Patients with: 1)Disease associated: ?History of sleep apnea syndrome ?Concomitant history of cognitive disorders, depression, schizophrenia, panic disorder, dementia, chronic pain, glaucoma, frequent nightly urination, significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, metabolic disorders ?History of suicidal tendency, fibromyalgia, seizures (excluding childhood febrile seizures), and chronic obstructive pulmonary disease. 2)Drug associated: ?Known hypersensitivity to any of study medications; ?Has participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of study medication ?Is required to take or intends to continue taking any disallowed medication or any prescription medication or over-the counter medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication, ?Has used any central nervous system medication or other drugs or supplements known to affect sleep pattern within 1 week prior to the administration of double-blind study medication. ?History of drug induced leucopenia/neutropenia/agranulocytosis 3)Investigations associated: ?Serious hepatic disease (SGPT/OT≥2.5 times UNL) ?Cardiac arrhythmia, QT prolongation or conditions predisposing for prolongation of QT interval ?Hyperglycemia (Random blood sugar ≥ 140 mg/dL) or diabetes mellitus ?Has any other clinically important abnormal finding 4)Requirement of sleep schedule changes as a part of his professional duty. 5)History of substance abuse including tobacco, alcohol and caffeine 6)As deemed inappropriate for enrollment by investigating physician due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the WASO (Wake time after sleep onset)Timepoint: At end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) latency to sleep onset (LSO) (2) Total sleep time (TST) (3) Sleep efficiency (SE) Timepoint: At end of the study | — |
Countries
India
Contacts
Public ContactDr Dimple Shah
Intas Pharma
Outcome results
None listed