Status:
TERMINATED
Milnacipran (Savella) in Irritable Bowel Syndrome (IBS)
Lead Sponsor:
Spencer Dorn, MD, MPH
Collaborating Sponsors:
Forest Laboratories
Conditions:
Irritable Bowel Syndrome
Eligibility:
FEMALE
18-79 years
Phase:
PHASE2
Brief Summary
Purpose: The investigators are proposing to examine the use of Savella® (Milnacipran) for treating irritable bowel syndrome (IBS) in women. Participants: Eligible participants will meet the Rome III ...
Detailed Description
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized primarily by abdominal pain associated with bowel dysfunction. Like many other painful functional somatic ...
Eligibility Criteria
Inclusion
- Meet Rome III criteria for IBS and have no red flags.
- Must have had a colonoscopy within the previous 5 years to exclude inflammatory or other bowel disease
- Be fluent and literate in English
- Must either be of non-childbearing potential or agree to utilize approved birth control for the duration of the study
Exclusion
- Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening.
- Any other diagnosis to explain the abdominal pain,
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurologic, psychiatric or any disease that may interfere with the subject successfully completing the trial
- Hepatic dysfunction (ALT \[SGPT\] or AST \[SGOT\] \>3 times the upper limit of normal) or renal impairment (serum creatinine \> 2mg/dL)
- Has disease affecting electrolytes balance, such as SIADH with serum Sodium less than 130mmol/L
- Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year
- Any surgery on the stomach, small intestine or colon, excluding appendectomy
- A major psychiatric disorder (DSM-III-R or DSM-IV) including major depression or other psychoses that has required hospitalization in the last 1 year.
- History of attempted suicide or uncontrolled bipolar disorder.
- Currently using antidepressants for psychiatric conditions like major depression. Use of TCA or SSRI class antidepressant acceptable if being used specifically for treatment of bowel symptoms and patient is willing to taper off the medication
- Previous use of Milnacipran or other SNRI antidepressant (duloxetine, venlafaxine, desvenlafaxine)
- A diagnosis of seizure disorder
- A diagnosis of glaucoma
- Currently taking heparin or warfarin
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01471379
Start Date
April 1 2012
End Date
February 1 2013
Last Update
April 13 2017
Active Locations (1)
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1
UNC Center for Functional GI and Motility Disorders
Chapel Hill, North Carolina, United States, 27599