Duloxetine for the Treatment of Chronic Pelvic Pain
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|ClinicalTrials.gov Identifier: NCT01451606|
Recruitment Status : Terminated (Adequate recruitment was not achieved in the time frame allowed.)
First Posted : October 13, 2011
Results First Posted : January 23, 2018
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pelvis Pain Chronic||Drug: Duloxetine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||One group receiving active drug treatment and second group receiving an indistinguishable placebo pill.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Study drug allocation was determined by University pharmacy, using a random allocation algorithm unknown by researchers or patients.|
|Official Title:||Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain|
|Actual Study Start Date :||July 11, 2011|
|Actual Primary Completion Date :||November 4, 2015|
|Actual Study Completion Date :||November 4, 2015|
Placebo Comparator: Placebo pill
A pill that looks like the active drug, but does not contain any active ingredients.
To serve as placebo for duloxetine. Administration schedule same as for active drug.
Other Name: Sugar pill
Active Comparator: Duloxetine
The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).
30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week
Other Name: Cymbalta
- Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale). [ Time Frame: Baseline and 8 weeks ]The primary clinical efficacy measure is the change in spontaneous (non-evoked) pelvic pain from the baseline period to the end of treatment. This was assessed by using the 0-10 numerical pain ratings to derive the primary outcome variable of clinical pain intensity difference due to treatment. Larger values (greater changes in ratings) are better outcomes.
- Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain [ Time Frame: Baseline and 8 weeks ]This is a questionnaire assessment of functional limitations due to clinical pain. The range of scores for this subscale is 0-44. The measure is the change in score from baseline to end of treatment period. A greater number (change in score) is a better outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451606
|United States, Maryland|
|University of Maryland, Baltimore|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Joel Greenspan, Ph.D.||University Of Maryland Dental School|