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Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00610675
First received: January 9, 2008
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate in Protocol 176004 (P05708) after signing informed consent.


Condition Intervention Phase
Insomnia
Drug: Org 50081
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fifty-Two Weeks, Open Label Extension Trial to Evaluate Safety and Efficacy of Org 50081 in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 176001 or 176002.

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With an Adverse Event [ Time Frame: Up to 57 weeks ] [ Designated as safety issue: Yes ]
    An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.

  • Number of Participants Who Discontinued Treatment Due to an Adverse Event [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
    An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.


Secondary Outcome Measures:
  • Change From Baseline in Total Sleep Time at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Total Sleep Time (TST) is a subjective time recorded by the participant in an electronic sleep diary in response to the question "How much time did you actually spend sleeping?". Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the last observation carried forward (LOCF) method, where the last available assessments prior to the scheduled observation were averaged.

  • Change From Baseline in Sleep Latency at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Sleep Latency (SL) is the time from when the participant went to bed up to the the time the participant actually fell asleep, recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.

  • Change From Baseline in Wake Time After Sleep Onset at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Wake time after sleep onset (WASO) is, if the planned waking time is on or after the time of final awakening, as follows: total time from falling asleep to the time of planned wake up minus the total sleep time. If the planned waking time is before the time of final awakening then WASO is as follows: total time from falling asleep to the time of actual final awakening minus the total sleep time. All times were recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.

  • Change From Baseline in Number of Awakenings at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Number of awakenings is a subjective number recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.

  • Change From Baseline in Quality of Sleep Scale at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Quality of Sleep is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.

  • Change From Baseline in Satisfaction With Sleep Duration Scale at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Satisfaction with Sleep Duration is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.


Enrollment: 346
Study Start Date: December 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esmirtazapine
One tablet of Esmirtazapine, 4.5 mg orally, daily for up to 52 weeks
Drug: Org 50081
One tablet daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations;
  • completed Protocol P05706 or P05707;
  • Have safety and efficacy assessments conducted per protocol P05706 or P05707.

Exclusion Criteria:

  • clinically relevant electrocardiogram (ECG) abnormalities as judged by the investigator;
  • clinically relevant abnormal laboratory values as judged by the investigator;
  • any adverse event deemed relevant for exclusion in Protocol P05708 as judged by the investigator or,
  • were significantly non compliant with protocol criteria and procedures of Protocol P05706 or P05707, as judged by the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610675

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00610675     History of Changes
Other Study ID Numbers: P05708, 176004
Study First Received: January 9, 2008
Results First Received: June 25, 2014
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Fifty two weeks
Open label
extension

ClinicalTrials.gov processed this record on November 24, 2014