Trial Outcomes & Findings for Duloxetine for the Treatment of Chronic Pelvic Pain (NCT NCT01451606)
NCT ID: NCT01451606
Last Updated: 2019-09-26
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2019-09-26
Participant Flow
Recruitment period: July 2011 - Dec. 2015. Recruitment from medical clinic and through public advertisements.
In person visit to complete eligibility screening.
Participant milestones
| Measure |
Placebo Pill
A pill that looks like the active drug, but does not contain any active ingredients.
Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug.
|
Duloxetine
The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).
Duloxetine: 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
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
18
|
|
Overall Study
COMPLETED
|
12
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Placebo Pill
A pill that looks like the active drug, but does not contain any active ingredients.
Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug.
|
Duloxetine
The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).
Duloxetine: 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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
Baseline Characteristics
Duloxetine for the Treatment of Chronic Pelvic Pain
Baseline characteristics by cohort
| Measure |
Placebo Pill
n=16 Participants
A pill that looks like the active drug, but does not contain any active ingredients.
Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug.
|
Duloxetine
n=18 Participants
The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).
Duloxetine: 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
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksThe 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.
Outcome measures
| Measure |
Placebo Pill
n=12 Participants
A pill that looks like the active drug, but does not contain any active ingredients.
Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug.
|
Duloxetine
n=15 Participants
The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).
Duloxetine: 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
|
|---|---|---|
|
Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale).
|
5 units on a scale
Interval 2.0 to 8.0
|
5 units on a scale
Interval 3.0 to 6.5
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksThis 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.
Outcome measures
| Measure |
Placebo Pill
n=12 Participants
A pill that looks like the active drug, but does not contain any active ingredients.
Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug.
|
Duloxetine
n=15 Participants
The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).
Duloxetine: 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
|
|---|---|---|
|
Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain
|
21.58 units on a scale
Standard Deviation 26.73
|
12.92 units on a scale
Standard Deviation 22.68
|
Adverse Events
Placebo Pill
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Duloxetine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Pill
n=12 participants at risk
A pill that looks like the active drug, but does not contain any active ingredients.
Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug.
|
Duloxetine
n=15 participants at risk
The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).
Duloxetine: 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
|
|---|---|---|
|
Nervous system disorders
Headache
|
41.7%
5/12 • Number of events 5 • Adverse Events (AEs) were recorded for the duration of a participants time in the study, including 2 weeks after end of treatment. For the entire study, AEs were noted from July 2011 - Dec. 2015.
|
33.3%
5/15 • Number of events 12 • Adverse Events (AEs) were recorded for the duration of a participants time in the study, including 2 weeks after end of treatment. For the entire study, AEs were noted from July 2011 - Dec. 2015.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • Number of events 4 • Adverse Events (AEs) were recorded for the duration of a participants time in the study, including 2 weeks after end of treatment. For the entire study, AEs were noted from July 2011 - Dec. 2015.
|
40.0%
6/15 • Number of events 11 • Adverse Events (AEs) were recorded for the duration of a participants time in the study, including 2 weeks after end of treatment. For the entire study, AEs were noted from July 2011 - Dec. 2015.
|
|
Nervous system disorders
Sleepiness
|
16.7%
2/12 • Number of events 2 • Adverse Events (AEs) were recorded for the duration of a participants time in the study, including 2 weeks after end of treatment. For the entire study, AEs were noted from July 2011 - Dec. 2015.
|
26.7%
4/15 • Number of events 9 • Adverse Events (AEs) were recorded for the duration of a participants time in the study, including 2 weeks after end of treatment. For the entire study, AEs were noted from July 2011 - Dec. 2015.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place