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

• ClinicalTrials.gov Identifier: NCT01181232
• Recruitment Status: Completed
• First Posted: August 13, 2010
• Last Update Posted: September 10, 2014
• Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Taiwan, Inc.
• Information provided by (Responsible Party): Astellas Pharma Inc

Tracking Information

• First Submitted Date: August 4, 2010
• First Posted Date: August 13, 2010
• Last Update Posted Date: September 10, 2014
• Study Start Date: October 2009
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 12, 2010)

• Rest/activity cycles measured by Actigraphy [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ]
• Total score of Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 12, 2010)

• Physician's clinical global impression (CGI) [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ]
• Patient's global impression (PGI) [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ]
• Sleep latency as derived from sleep diary [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ]
• Number of awakenings as derived from sleep diary [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ]
• Total sleep time as derived from sleep diary [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ]
• Wake time after sleep onset as derived from sleep diary [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ]
• Day time function as assessed by Epworth Sleepiness Scale (ESS) [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients
• Official Title: A Randomized, Active Control, Parallel Study to Evaluate the Efficacy and Safety of Zolpidem MR (Stilnox CR) Versus Zolpidem (Stilnox) in Patients With Primary Insomnia
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Sleep Initiation and Maintenance Disorders
• Primary Insomnia

Intervention

• Drug: Zolpidem MR
  oral
  Other Names:

  • Stilnox CR
  • Ambient CR
• Drug: Zolpidem IR
  oral
  Other Name: Stilnox

Study Arms

• Experimental: MR low-dose group
  Intervention: Drug: Zolpidem MR
• Experimental: MR high-dose group
  Intervention: Drug: Zolpidem MR
• Active Comparator: IR group
  Intervention: Drug: Zolpidem IR

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 5, 2011): 132
• Original Estimated Enrollment (submitted: August 12, 2010): 180
• Actual Study Completion Date: April 2011
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT01181232
• Other Study ID Numbers: STCR-0901-TW
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Astellas Pharma Inc
• Study Sponsor: Astellas Pharma Inc
• Collaborators: Astellas Pharma Taiwan, Inc.

Investigators

• Study Chair: Use Central Contact; Astellas Pharma Inc

• PRS Account: Astellas Pharma Inc
• Verification Date: August 2014