Duloxetine for the Treatment of Chronic Pelvic Pain
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pelvis Pain Chronic |
Drug: Duloxetine Drug: Sugar Pill |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain |
- The primary clinical efficacy measure is reduction in spontaneous (non-evoked) pelvic pain. This will be assessed by using the 0-10 numerical pain ratings to derive the primary outcome variable of clinical pain intensity difference due to treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Functional limitations due to pain [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]A questionnaire assessment of functional limitations due to clnical pain
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Sugar Pill |
Drug: Sugar Pill
To serve as placebo for duloxetine. Administration schedule same as for active drug.
|
| Active Comparator: Duloxetine |
Drug: 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
Other Name: Cymbalta
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- premenopausal adult women, aged 18-30
- 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 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 IBS, IC/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 DSM-IV criteria will excluded, as well as those selecting "3" or "4" on item #9 of the 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 AST,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 SSRIs, SSNRIs, 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
Contacts and Locations| Contact: Nicole Ward, B.A. | 443-740-5452 | cpp@umaryland.edu |
| United States, Maryland | |
| University of Maryland, Baltimore | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Nicole Ward 443-740-5452 cpp@umaryland.edu | |
| Principal Investigator: Joel Greenspan, Ph.D. | |
| Sub-Investigator: Vadim Morozov, M.D. | |
| Principal Investigator: | Joel Greenspan, Ph.D. | University Of Maryland Dental School |
More Information
No publications provided
| Responsible Party: | Joel Greenspan, Professor and Chair, University of Maryland |
| ClinicalTrials.gov Identifier: | NCT01451606 History of Changes |
| Other Study ID Numbers: | F1J-US-X062 |
| Study First Received: | October 11, 2011 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Maryland:
|
Chronic Pelvic Pain CPP Pelvic Pain |
Additional relevant MeSH terms:
|
Pelvic Pain Pain Signs and Symptoms Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents |
Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013