Duloxetine for the Treatment of Chronic Pelvic Pain
|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 : January 23, 2018
|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.
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|