Milnacipran (Savella) in Irritable Bowel Syndrome (IBS)

NCT ID: NCT01471379

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-02-28

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 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.

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 syndromes (e.g. fibromyalgia) the pathophysiology of IBS includes abnormal responses to pain and dysregulation of brain-body pain pathways. IBS affects up to 10% of the population, is a leading reason for visits to gastroenterologists and primary care doctors, and, in the United States, annually accrues health care costs over $20 billion.

In their practice the investigators use centrally acting agents to treat IBS. Historically, the investigators have used tricyclic antidepressants based on results of clinical trials, including our NIH funded trial on desipramine. Nonetheless, these agents can produce side effects that limit their full application. More recently the investigators have begun to use SNRIs because they have been shown to benefit for various pain syndromes like diabetic neuropathy, fibromyalgia. The initial impression is that Milnacipran helps improve IBS symptoms and global well being. There is now a need to systematically determine Milnacipran's value for IBS.

Conditions

Irritable Bowel Syndrome

Study Design

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

Study Groups

Group A (50mg - 100mg)

Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II

Group Type: EXPERIMENTAL

Milnacipran

Intervention Type: DRUG

50mg Milnacipran PO, BID, for 6 weeks.

Milnacipran

Intervention Type: DRUG

Milnacipran, 100mg PO, BID, for six weeks

Group B (50mg x12)

Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.

Group Type: ACTIVE_COMPARATOR

Milnacipran

Intervention Type: DRUG

Milnacipran, 50mg PO BID for 12 weeks

Group C (Placebo - 50mg)

Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II

Group Type: PLACEBO_COMPARATOR

Milnacipran

Intervention Type: DRUG

50mg Milnacipran PO, BID, for 6 weeks.

Placebo

Intervention Type: DRUG

Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.

Interventions

Milnacipran

50mg Milnacipran PO, BID, for 6 weeks.

Intervention Type: DRUG

Milnacipran

Milnacipran, 100mg PO, BID, for six weeks

Intervention Type: DRUG

Milnacipran

Milnacipran, 50mg PO BID for 12 weeks

Intervention Type: DRUG

Placebo

Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.

Intervention Type: DRUG

Other Intervention Names

Savella; Savella; Savella

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Spencer Dorn, MD, MPH

OTHER

Sponsor Role: lead

Responsible Party

Spencer Dorn, MD, MPH

Assistant Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Spencer D Dorn, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC Center for Functional GI and Motility Disorders

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

11-1105a

Identifier Type: -

Identifier Source: org_study_id