Pelvis Pain ChronicPhase 4NCT01451606
Duloxetine for the Treatment of Chronic Pelvic Pain
A Phase 4 study testing Duloxetine in people with Pelvis Pain Chronic, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pelvis Pain Chronic
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2011to 4 Nov 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain
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.
Read the 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
- Being tested
- Duloxetine, Placebo
- Keywords
- Chronic Pelvic Pain (CPP), Pelvic Pain
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
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
PlaceboDrug
Also called Sugar pill
To serve as placebo for duloxetine. Administration schedule same as for active drug.
| Study group | Role | What they receive |
|---|---|---|
| Placebo pill | Placebo comparator | A pill that looks like the active drug, but does not contain any active ingredients. Receives: Drug: Placebo |
| Duloxetine | Active comparator | The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI). Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (1)
Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain
This is a questionnaire assessment of functional limitations due to clinical pain. The range of scores for this subscale is 0-44. The measure is the change in score from baseline to end of treatment period. A greater number (change in score) is a better outcome.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study start11 Jul 2011
- Primary completion4 Nov 2015
- Study completion4 Nov 2015
Why it stopped: Adequate recruitment was not achieved in the time frame allowed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pelvis Pain ChronicStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group receiving active drug treatment and second group receiving an indistinguishable placebo pill.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Joel Greenspan, University of Maryland, Baltimore
- Investigators
- Joel Greenspan, Ph.D., Principal investigator, University Of Maryland Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451606
- Sponsor's protocol ID
- HP-00047688
- Status last verified
- Sep 2019
- First submitted
- 11 Oct 2011
- Last updated
- 26 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT01451606
- Acronym / sponsor ID
- HP-00047688
- Conditions
- Pelvis Pain Chronic
- Keywords
- Chronic Pelvic Pain (CPP), Pelvic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adequate recruitment was not achieved in the time frame allowed.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 11 Jul 2011 (actual)
- Primary completion
- 4 Nov 2015 (actual)
- Study completion
- 4 Nov 2015 (actual)
- First posted
- 13 Oct 2011 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- One group receiving active drug treatment and second group receiving an indistinguishable placebo pill.
| Arm | Type | Receives |
|---|---|---|
| Placebo pill | Placebo comparator | Drug: PlaceboA pill that looks like the active drug, but does not contain any active ingredients. |
| Duloxetine | Active comparator | Drug: DuloxetineThe drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: Cymbalta30 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 | Drug | Duloxetine |
| PlaceboAlso: Sugar pillTo serve as placebo for duloxetine. Administration schedule same as for active drug. | Drug | Placebo pill |
Primary outcome
Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale).
Time frame: Baseline and 8 weeks
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.
1 secondary outcome
Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Greenspan, Ph.D. principal investigator
University Of Maryland Dental School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine in people with Pelvis Pain Chronic, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale). (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.