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Trial record 14 of 424 for:    Pregabalin

Pregabalin for the Treatment of Vulvodynia

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ClinicalTrials.gov Identifier: NCT00853229
Recruitment Status : Terminated (Not feasible due to low accrual)
First Posted : March 2, 2009
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Vulvodynia
Vulvar Vestibulitis
Intervention Drug: pregabalin
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pregabalin First 4 Weeks Placebo First 4 Weeks
Hide Arm/Group Description

pregabalin and placebo given using a cross-over design

pregabalin: pregabalin 150mg twice daily for 4 weeks

placebo and pregabalin given using a cross-over design

pregabalin: pregabalin 150mg twice daily for 4 weeks

Period Title: Phase 1: Initial Intervention
Started 8 8
Completed 0 0
Not Completed 8 8
Reason Not Completed
Early study termination, poor enrollment             8             8
Period Title: Phase 2: Cross Over
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Pregabalin First 4 Weeks Placebo First 4 Weeks Total
Hide Arm/Group Description

pregabalin and placebo given using a cross-over design

pregabalin: pregabalin 150mg twice daily for 4 weeks

placebo and pregabalin given using a cross-over design

pregabalin: pregabalin 150mg twice daily for 4 weeks

Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
No study analysis completed due to early termination due to poor enrollment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
35.0  (8.9) 36.3  (13.1) 35.6  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
8
 100.0%
8
 100.0%
16
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8 8 16
1.Primary Outcome
Title Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10)
Hide Description Outcomes measure not assessed due to early discontinuation because of poor recruitment. As such, the study was terminated prior to the designated follow up interval. Therefore, no outcomes data was collected.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin/Placebo Placebo/Pregabalin
Hide Arm/Group Description:

pregabalin and placebo given using a cross-over design

pregabalin: pregabalin 150mg twice daily for 4 weeks

placebo and pregabalin given using a cross-over design

pregabalin: pregabalin 150mg twice daily for 4 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10)
Hide Description Data not measured due to early discontinuation of the study prior to the designated follow up time frame.
Time Frame 4 weeks
Outcome Measure Data Not Reported
Time Frame 4 weeks
Adverse Event Reporting Description Data not collected. Long term follow up not available for adverse events as study was discontinued early.
 
Arm/Group Title Pregabalin/Placebo Placebo/Pregabalin
Hide Arm/Group Description

pregabalin and placebo given using a cross-over design

pregabalin: pregabalin 150mg twice daily for 4 weeks

placebo and pregabalin given using a cross-over design

pregabalin: pregabalin 150mg twice daily for 4 weeks

All-Cause Mortality
Pregabalin/Placebo Placebo/Pregabalin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin/Placebo Placebo/Pregabalin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregabalin/Placebo Placebo/Pregabalin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Lynn Borzi (Research Administrator)
Organization: Cleveland Clinic
Phone: 216-445-3158
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00853229     History of Changes
Other Study ID Numbers: CCF 08-195
First Submitted: February 27, 2009
First Posted: March 2, 2009
Results First Submitted: January 10, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017