A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients

NCT01181232 | Completed Phase 4

• 1 other identifier: STCR-0901-TW
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.

Conditions

Sleep Initiation and Maintenance Disorders; Primary Insomnia

Keywords

insomnia; zolpidem

Outcome Measures

Primary Outcomes (2)

• Rest/activity cycles measured by Actigraphy

  For 2 weeks (Day 0, Day 7, Day 14)

• Total score of Pittsburgh Sleep Quality Index (PSQI)

  For 2 weeks (Day 0, Day 7, Day 14)

Secondary Outcomes (7)

• Physician's clinical global impression (CGI)

  For 2 weeks (Day 0, Day 7, Day 14)

• Patient's global impression (PGI)

  For 2 weeks (Day 0, Day 7, Day 14)

• Sleep latency as derived from sleep diary

  For 2 weeks (Day 0, Day 7, Day 14)

• Number of awakenings as derived from sleep diary

  For 2 weeks (Day 0, Day 7, Day 14)

• Total sleep time as derived from sleep diary

  For 2 weeks (Day 0, Day 7, Day 14)

Study Arms (3)

MR low-dose group

EXPERIMENTAL

Drug: Zolpidem MR

MR high-dose group

EXPERIMENTAL

Drug: Zolpidem MR

IR group

ACTIVE COMPARATOR

Drug: Zolpidem IR

Interventions

Zolpidem MR DRUG

oral

Also known as: Stilnox CR, Ambient CR

MR high-dose group; MR low-dose group

Zolpidem IR DRUG

oral

Also known as: Stilnox

IR group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of primary insomnia based on DSM-IV criteria (307.42)
• Written informed consent has been obtained

You may not qualify if:

• Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome
• Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem
• Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week)
• Patients who have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study
• Patients who are pregnant, lactating or intend to become pregnant during the study period
• Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study
• Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
• Participation in any clinical trial within 1 month prior to randomization

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Taiwan, Inc.: collaborator

Study Sites (2)

Unknown Facility

Tainan, 704, Taiwan

Location

Unknown Facility

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 13, 2010
• Study Start: October 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 10, 2014

Record last verified: 2014-08

Locations

TW (2)