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Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00560833
First received: November 16, 2007
Last updated: May 28, 2014
Last verified: May 2014
Results First Received: May 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Menopause
Vasomotor Symptoms
Interventions: Drug: esmirtazapine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
942 participants were randomly assigned to treatment in this study, however, one screened participant was given placebo treatment without a randomization assignment. This participant is included in the study placebo population.

Reporting Groups
  Description
Placebo Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
Esmirtazapine 2.25 mg Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
Esmirtazapine 4.5 mg Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
Esmirtazapine 9 mg Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
Esmirtazapine 18mg Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks

Participant Flow:   Overall Study
    Placebo     Esmirtazapine 2.25 mg     Esmirtazapine 4.5 mg     Esmirtazapine 9 mg     Esmirtazapine 18mg  
STARTED     317     155     160     155     156  
Treated     317 [1]   154 [2]   160     155     155 [2]
COMPLETED     273     129     121     124     114  
NOT COMPLETED     44     26     39     31     42  
Adverse Event                 16                 10                 25                 23                 35  
Lost to Follow-up                 0                 0                 1                 0                 0  
Lack of Efficacy                 22                 9                 6                 4                 4  
Participant uncooperative                 5                 5                 4                 4                 2  
Unspecified                 1                 1                 3                 0                 0  
Never received drug                 0                 1                 0                 0                 1  
[1] One participant was not randomized but was treated with placebo
[2] One participant was randomized but not treated



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received any study drug (placebo or esmertazapine), whether or not randomized.

Reporting Groups
  Description
Placebo Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
Esmirtazapine 2.25 mg Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
Esmirtazapine 4.5 mg Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
Esmirtazapine 9 mg Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
Esmertazapine 18 mg Participants receive esmertazapine 18 mg, encapsulated tablet, PO, QD for up to 12 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     Esmirtazapine 2.25 mg     Esmirtazapine 4.5 mg     Esmirtazapine 9 mg     Esmertazapine 18 mg     Total  
Number of Participants  
[units: participants]
  317     154     160     155     155     941  
Age  
[units: Years]
Mean ± Standard Deviation
  54.0  ± 4.4     53.4  ± 4.4     54.1  ± 4.2     54.9  ± 4.8     54.1  ± 4.5     54.1  ± 4.4  
Gender  
[units: Participants]
           
Female     317     154     160     155     155     941  
Male     0     0     0     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 4   [ Time Frame: Baseline and Week 4 ]

2.  Primary:   Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 12   [ Time Frame: Baseline and Week 12 ]

3.  Primary:   Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 4   [ Time Frame: Baseline and Week 4 ]

4.  Primary:   Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 12   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Change From Baseline in Vasomotor Symptoms Score Per Women's Health Questionnaire (WHQ) at Week 12   [ Time Frame: Baseline and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00560833     History of Changes
Other Study ID Numbers: P06459, 46101, MK-8265-012, 2004-000469-36
Study First Received: November 16, 2007
Results First Received: May 28, 2014
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Hungary: National Institute of Pharmacy
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency