Duloxetine for the Treatment of Chronic Pelvic Pain

NCT ID: NCT01451606

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-11
• Study Completion Date: 2015-11-04

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.

Conditions

Pelvis Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo pill

A pill that looks like the active drug, but does not contain any active ingredients.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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).

Group Type: ACTIVE_COMPARATOR

Duloxetine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo

To serve as placebo for duloxetine. Administration schedule same as for active drug.

Intervention Type: DRUG

Other Intervention Names

Cymbalta; Sugar pill

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:

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Joel Greenspan

Professor and Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel Greenspan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Of Maryland Dental School

Locations

University of Maryland, Baltimore

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00047688

Identifier Type: -

Identifier Source: org_study_id