MedTrace Logo

Milnacipran (Savella) in Irritable Bowel Syndrome (IBS)

NCT01471379 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-04-13

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Milnacipran

50mg Milnacipran PO, BID, for 6 weeks.

DRUG

Milnacipran

Milnacipran, 100mg PO, BID, for six weeks

DRUG

Milnacipran

Milnacipran, 50mg PO BID for 12 weeks

DRUG

Placebo

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

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Spencer Dorn, MD, MPH

    lead OTHER

Principal Investigators

  • Spencer D Dorn, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01471379 on ClinicalTrials.gov