NCT00466193

Brief Summary

The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
295

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

January 20, 2012

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

6 months

First QC Date

April 24, 2007

Results QC Date

December 15, 2011

Last Update Submit

February 10, 2012

Conditions

Insomnia

Keywords

Insomnia

Outcome Measures

Primary Outcomes (2)

  • Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline

    Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?

    Weeks -1 to 0

  • Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment

    Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?

    Weeks 1 to 4

Secondary Outcomes (8)

  • Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline

    Weeks -1 to 0

  • Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment

    Weeks 1 to 4

  • Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.

    Weeks -1 to 0

  • Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment

    Weeks 1 to 4

  • Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline

    Weeks -1 to 0

  • +3 more secondary outcomes

Study Arms (2)

Zolpidem 3.5mg

EXPERIMENTAL
Drug: zolpidem tartrate sublingual tablet

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

zolpidem tartrate sublingual tabletDRUG

3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Also known as: Intermezzo®
Zolpidem 3.5mg
PlaceboDRUG

Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults with history of sleeplessness

You may not qualify if:

  • Allergic to investigational drug
  • Any conditions and medications that may interfere with study drug evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Transcept Investigational Site

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Clinical Leader
Organization
Purdue Pharma LP
800-733-1333

Study Officials

  • Andrew Krystal, MD

    Clinical Neurophysiology Training Program, Duke University

    PRINCIPAL INVESTIGATOR

  • Thomas Roth, PhD

    Sleep Disorders and Research Center, Henry Ford Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2007

First Posted

April 27, 2007

Study Start

May 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

February 14, 2012

Results First Posted

January 20, 2012

Record last verified: 2012-02

Locations

US(1)