Duloxetine for the Treatment of Chronic Pelvic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Maryland
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Joel Greenspan, University of Maryland
ClinicalTrials.gov Identifier:
NCT01451606
First received: October 11, 2011
Last updated: December 18, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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:

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451606

Contacts
Contact: Nicole Ward, B.A. 443-740-5452 cpp@umaryland.edu

Locations
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.         
Sponsors and Collaborators
University of Maryland
Eli Lilly and Company
Investigators
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 July 28, 2014