Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Depomed
ClinicalTrials.gov Identifier:
NCT00777023
First received: October 21, 2008
Last updated: February 21, 2012
Last verified: February 2012
Results First Received: January 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Hot Flashes
Interventions: Drug: Gabapentin Extended-Release (G-ER) 1200 mg
Drug: Gabapentin Extended-Release (G-ER) 1800 mg
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
A total of 565 patients were randomly assigned to treatment: 190 in G-ER 1800 mg group, 192 in G-ER 1200 mg group, and 183 in placebo group. Of these 565 patients, 559 patients (190 in G-ER 1800 mg group, 186 in 1200 mg group, and 183 in placebo group) received study treatment and were included in intent to treat (ITT) and safety populations.

Reporting Groups
  Description
G-ER 1200 mg Gabapentin extended-release (G-ER) 1200 mg
G-ER 1800 mg Gabapentin extended-release (G-ER) 1800 mg
Sugar Pill Placebo 1200 mg or 1800 mg

Participant Flow:   Overall Study
    G-ER 1200 mg     G-ER 1800 mg     Sugar Pill  
STARTED     186 [1]   190 [2]   183 [3]
COMPLETED     151     149     146  
NOT COMPLETED     35     41     37  
Adverse Event                 15                 21                 8  
Lack of Efficacy                 1                 0                 14  
Protocol Violation                 2                 1                 1  
Lost to Follow-up                 2                 3                 3  
Death                 0                 1                 0  
Withdrawal by Subject                 7                 7                 8  
Missing data                 1                 1                 0  
Reasons not specified                 4                 4                 2  
Last dose date unknown                 3                 3                 1  
[1] 192 patients were randomized, but only 186 received study treatment.
[2] 190 patients were randomized, and 190 received study treatment.
[3] 183 patients were randomized, and 183 received study treatment.



  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.
No text entered.

Reporting Groups
  Description
G-ER 1200 mg Gabapentin extended-release (G-ER) 1200 mg
G-ER 1800 mg Gabapentin extended-release (G-ER) 1800 mg
Sugar Pill Placebo 1200 mg or 1800 mg
Total Total of all reporting groups

Baseline Measures
    G-ER 1200 mg     G-ER 1800 mg     Sugar Pill     Total  
Number of Participants  
[units: participants]
  186     190     183     559  
Age  
[units: years]
Mean ± Standard Deviation
  53.1  ± 7.0     53.6  ± 6.1     52.9  ± 6.0     53.2  ± 6.4  
Age, Customized  
[units: participants]
       
<65 years     175     181     177     533  
>=65 years     11     9     6     26  
Gender  
[units: participants]
       
Female     186     190     183     559  
Male     0     0     0     0  
Frequency of hot flashes [1]
[units: Hot flashes]
Mean ± Standard Deviation
       
Mild     1.1  ± 2.0     1.0  ± 2.0     1.7  ± 2.9     1.2  ± 2.3  
Moderate     6.1  ± 5.8     5.4  ± 4.0     6.2  ± 5.1     5.9  ± 5.0  
Severe     6.7  ± 5.1     6.9  ± 5.5     6.6  ± 4.9     6.8  ± 5.2  
[1] Number of hot flashes in a 24-hour period.



  Outcome Measures
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1.  Primary:   Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment   [ Time Frame: At baseline and 4 weeks of treatment ]

2.  Primary:   Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment   [ Time Frame: At baseline and 12 weeks of treatment ]

3.  Primary:   Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment   [ Time Frame: At baseline and 4 weeks of treatment ]

4.  Primary:   Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment   [ Time Frame: At baseline and 12 weeks of treatment ]


  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
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  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Head of R&D
Organization: Depomed
phone: 650-462-5900 ext 108
e-mail: msweeney@depomed.com


No publications provided


Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT00777023     History of Changes
Other Study ID Numbers: BREEZE 2, 81-0059
Study First Received: October 21, 2008
Results First Received: January 16, 2012
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration