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Duloxetine for the Treatment of Chronic Pelvic Pain

Information source: University of Maryland
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pelvis Pain Chronic

Intervention: Duloxetine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Maryland

Official(s) and/or principal investigator(s):
Joel Greenspan, Ph.D., Principal Investigator, Affiliation: University Of Maryland Dental School

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.

Clinical Details

Official title: Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: Functional limitations due to pain

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

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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 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:

1. Known hypersensitivity to duloxetine or the inactive ingredients in Cymbalta; 2. 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; 3. Treatment with cytochrome P450 enzyme inhibitors; 4. Uncontrolled narrow-angle glaucoma; 5. Concurrent use of thioridazine 6. Renal Impairment (serum creatinine of 1. 5 or greater) 7. History of jaundice or hepatomegaly 8. 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

Locations and Contacts

University of Maryland, Baltimore, Baltimore, Maryland 21201, United States
Additional Information

Starting date: June 2011
Last updated: April 2, 2015

Page last updated: August 20, 2015

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