Duloxetine for the Treatment of Chronic Pelvic Pain

NCT01451606 | Terminated Phase 4 Results DMC

• 1 other identifier: HP-00047688
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvis Pain Chronic

Keywords

Chronic Pelvic Pain (CPP); Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 8 weeks

Secondary Outcomes (1)

• Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain

  Baseline and 8 weeks

Study Arms (2)

Placebo pill

PLACEBO COMPARATOR

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

Drug: Placebo

Duloxetine

ACTIVE COMPARATOR

The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).

Drug: Duloxetine

Interventions

Duloxetine 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

Also known as: Cymbalta

Duloxetine

Placebo DRUG

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

Also known as: Sugar pill

Placebo pill

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Pelvic Pain

Interventions

Duloxetine Hydrochloride; Sugars

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Dr. Joel Greenspan
• Organization: University of Maryland, Baltimore

jgreenspan@umaryland.edu

4107067090

Study Officials

• Joel Greenspan, Ph.D.

  University Of Maryland Dental School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study drug allocation was determined by University pharmacy, using a random allocation algorithm unknown by researchers or patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Model Details: One group receiving active drug treatment and second group receiving an indistinguishable placebo pill.

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 13, 2011
• Study Start: July 11, 2011
• Primary Completion: November 4, 2015
• Study Completion: November 4, 2015
• Last Updated: September 26, 2019
• Results First Posted: January 23, 2018

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)