Milnacipran (Savella) in Irritable Bowel Syndrome (IBS)

NCT01471379 | Terminated Phase 2 Results

• 1 other identifier: 11-1105a
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; IBS; Savella; Milnacipran; Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Pain Response

  Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain before the beginning of the study, at 6 weeks of treatment and at the end visit i.e. 10 weeks. Ideally, VAS would have been administered at the 12th week; however, subject was terminated at the 10th week visit. A positive pain response (ie pain relief) was defined as \>30% decrease in the VAS score between baseline and the final study visit.

  Twelve Weeks

Secondary Outcomes (4)

• Quality of Life ( IBS-QOL)

  Six Weeks

• Subject Self Reported Adequate Relief of Pain

  Twelve Weeks

• Treatment Efficacy Questionnaire (TEQ)

  Twelve Weeks

• Dose Related Incremental Benefit in Pain Reduction Based on VAS

  12 Weeks

Study Arms (3)

Group A (50mg - 100mg)

EXPERIMENTAL

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

Drug: Milnacipran

Group B (50mg x12)

ACTIVE COMPARATOR

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

Drug: Milnacipran

Group C (Placebo - 50mg)

PLACEBO COMPARATOR

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

Drug: Milnacipran; Drug: Placebo

Interventions

Milnacipran DRUG

50mg Milnacipran PO, BID, for 6 weeks.

Also known as: Savella

Group A (50mg - 100mg); Group C (Placebo - 50mg)

Placebo DRUG

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

Group C (Placebo - 50mg)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spencer Dorn, MD, MPH: lead
• Forest Laboratories: collaborator

Study Sites (1)

UNC Center for Functional GI and Motility Disorders

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Spencer Dorn Associate Professor
• Organization: UNC Chapel Hill

sdorn@med.unc.edu

919-966-0141

Study Officials

• Spencer D Dorn, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 16, 2011
• Study Start: April 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 13, 2017
• Results First Posted: December 24, 2013

Record last verified: 2017-03

Locations

US (1)