Milnacipran (Savella) in Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Milnacipran; Milnacipran; Milnacipran; Placebo
Intervention description: 50mg Milnacipran PO, BID, for 6 weeks.; Milnacipran, 100mg PO, BID, for six weeks; Milnacipran, 50mg PO BID for 12 weeks; Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Irritable Bowel Syndrome; IBS; Savella; Milnacipran; Abdominal Pain

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 diagnostic criteria for IBS.

      Procedures: This study will observe patients treated with Savella® as well as patients
      treated with a placebo (pill with no active drug). The investigators will monitor and compare
      several patient and symptom related outcomes, as well as evaluate health related quality of
      life, psychological distress and related psychosocial measures to determine if the addition
      of Savella® improves clinical pain response as well as secondary outcomes including quality
      of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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