Back to resultsDuloxetine for the Treatment of Chronic Pelvic Pain
Primary Purpose
Pelvis Pain Chronic
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pelvis Pain Chronic focused on measuring Chronic Pelvic Pain (CPP), Pelvic Pain
Eligibility Criteria
Inclusion Criteria:
- premenopausal adult women, aged 18-50
- Have chronic pelvic pain, as defined by the American College of Obstetrics and Gynecology
- Able to read and speak English
Exclusion Criteria:
- Chronic Pelvic Pain (CPP) only presenting in low back or vulva, or only present during menstruation or vaginal intercourse
- Self-report or documentation that all CPP sites were attributed by a prior physician to Irritable Bowel Syndromd (IBS), Interstitial cystitis (IC)/painful bladder syndrome (PBS), urinary tract infection, urinary stones, inflammatory bowel disease (ulcerative colitis or Crohn's disease), cancer or shingles.
- Currently pregnant or lactating
- A primary psychiatric diagnosis of major depression or history of suicide attempt as assessed by medical history. Also, those who would be considered to have Major Depressive Disorder (MDD) on the basis of the Diagnostic and Statistical Manual IV (DSM-IV) criteria will excluded, as well as those selecting "3" or "4" on item #9 of the Beck Depression Inventory (BDI; suicidal ideation).
- A history of bipolar disorder
- A history of seizure disorders
- Orthostatic Hypertension
Exclusions based on the effects of duloxetine:
- Known hypersensitivity to duloxetine or the inactive ingredients in Cymbalta;
- Treatment with an monoamine oxidase inhibitor (MAOI) within 14 days of randomization, or potential need to use an MAOI during the study or within 5 days of discontinuation of the drug;
- Treatment with cytochrome P450 enzyme inhibitors;
- Uncontrolled narrow-angle glaucoma;
- Concurrent use of thioridazine
- Renal Impairment (serum creatinine of 1.5 or greater)
- History of jaundice or hepatomegaly
- Hepatic Insufficiency (elevated aspartate transaminase (AST), alanine transaminase (ALT), bilirubin, or Alkaline Phosphatase), tested at the screening period, after the first week of study medication, and again at the midpoint of the study.
- Participants who are taking Selective serotonin reuptake inhibitors (SSRIs), Selective serotonin and norepinephrine reuptake inhibitors (SSNRIs), monoamine oxidase inhibitors (MAOIs), or tricyclics within 14 days of randomization will be excluded.
- Participants who currently meet DSM-IV diagnostic criteria for Alcohol Abuse or Dependence
- Weight exceeding 285 pounds
- Hyponatremia, as determined by blood test results
Sites / Locations
- University of Maryland, Baltimore
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo pill
Duloxetine
Arm Description
A pill that looks like the active drug, but does not contain any active ingredients.
The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).
Outcomes
Primary Outcome Measures
Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale).
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.
Secondary Outcome Measures
Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain
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.
Full Information
NCT ID
NCT01451606
First Posted
October 11, 2011
Last Updated
September 24, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT01451606
Brief Title
Duloxetine for the Treatment of Chronic Pelvic Pain
Official Title
Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Adequate recruitment was not achieved in the time frame allowed.
Study Start Date
July 11, 2011 (Actual)
Primary Completion Date
November 4, 2015 (Actual)
Study Completion Date
November 4, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is examining the effectiveness of duloxetine as a treatment for chronic pelvic pain in women. Duloxetine is FDA approved for the treatment of other pain conditions, including fibromyalgia and diabetic neuropathy.
Detailed Description
Chronic pelvic pain in women can be caused by various pathologies, such as endometriosis, fibroids, and adhesions. Surgical treatment of the pathology often relieves the pain, but a significant number of women continue to have pain, even after visibly successful surgery. One model explored in this study is that in some cases of chronic pelvic pain, the central nervous system has changed in its processing of pain-related signals, requiring a therapy directed to the Central Nervous System (CNS) to effectively treat the pain. This model has been supported in studies of other chronic pain conditions, such as fibromyalgia and migraine. This study will seek to determine whether the analgesic effectiveness of duloxetine is related to the pain state of the individual.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvis Pain Chronic
Keywords
Chronic Pelvic Pain (CPP), Pelvic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
One group receiving active drug treatment and second group receiving an indistinguishable placebo pill.
Masking
ParticipantInvestigator
Masking Description
Study drug allocation was determined by University pharmacy, using a random allocation algorithm unknown by researchers or patients.
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo pill
Arm Type
Placebo Comparator
Arm Description
A pill that looks like the active drug, but does not contain any active ingredients.
Arm Title
Duloxetine
Arm Type
Active Comparator
Arm Description
The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
To serve as placebo for duloxetine. Administration schedule same as for active drug.
Primary Outcome Measure Information:
Title
Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale).
Description
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.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain
Description
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.
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
premenopausal adult women, aged 18-50
Have chronic pelvic pain, as defined by the American College of Obstetrics and Gynecology
Able to read and speak English
Exclusion Criteria:
Chronic Pelvic Pain (CPP) only presenting in low back or vulva, or only present during menstruation or vaginal intercourse
Self-report or documentation that all CPP sites were attributed by a prior physician to Irritable Bowel Syndromd (IBS), Interstitial cystitis (IC)/painful bladder syndrome (PBS), urinary tract infection, urinary stones, inflammatory bowel disease (ulcerative colitis or Crohn's disease), cancer or shingles.
Currently pregnant or lactating
A primary psychiatric diagnosis of major depression or history of suicide attempt as assessed by medical history. Also, those who would be considered to have Major Depressive Disorder (MDD) on the basis of the Diagnostic and Statistical Manual IV (DSM-IV) criteria will excluded, as well as those selecting "3" or "4" on item #9 of the Beck Depression Inventory (BDI; suicidal ideation).
A history of bipolar disorder
A history of seizure disorders
Orthostatic Hypertension
Exclusions based on the effects of duloxetine:
Known hypersensitivity to duloxetine or the inactive ingredients in Cymbalta;
Treatment with an monoamine oxidase inhibitor (MAOI) within 14 days of randomization, or potential need to use an MAOI during the study or within 5 days of discontinuation of the drug;
Treatment with cytochrome P450 enzyme inhibitors;
Uncontrolled narrow-angle glaucoma;
Concurrent use of thioridazine
Renal Impairment (serum creatinine of 1.5 or greater)
History of jaundice or hepatomegaly
Hepatic Insufficiency (elevated aspartate transaminase (AST), alanine transaminase (ALT), bilirubin, or Alkaline Phosphatase), tested at the screening period, after the first week of study medication, and again at the midpoint of the study.
Participants who are taking Selective serotonin reuptake inhibitors (SSRIs), Selective serotonin and norepinephrine reuptake inhibitors (SSNRIs), monoamine oxidase inhibitors (MAOIs), or tricyclics within 14 days of randomization will be excluded.
Participants who currently meet DSM-IV diagnostic criteria for Alcohol Abuse or Dependence
Weight exceeding 285 pounds
Hyponatremia, as determined by blood test results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Greenspan, Ph.D.
Organizational Affiliation
University Of Maryland Dental School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Duloxetine for the Treatment of Chronic Pelvic Pain
We'll reach out to this number within 24 hrs