Milnacipran (Savella) in Irritable Bowel Syndrome (IBS)
|ClinicalTrials.gov Identifier: NCT01471379|
Recruitment Status : Terminated (Due to recruitment difficulties the study is terminated.)
First Posted : November 16, 2011
Results First Posted : December 24, 2013
Last Update Posted : April 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Drug: Milnacipran Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Milnacipran in the Treatment of Irritable Bowel Syndrome|
|Study Start Date :||April 2012|
|Primary Completion Date :||February 2013|
|Study Completion Date :||February 2013|
Experimental: 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
50mg Milnacipran PO, BID, for 6 weeks.
Other Name: SavellaDrug: Milnacipran
Milnacipran, 100mg PO, BID, for six weeks
Other Name: Savella
Active Comparator: 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.
Milnacipran, 50mg PO BID for 12 weeks
Other Name: Savella
Placebo Comparator: 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
50mg Milnacipran PO, BID, for 6 weeks.
Other Name: SavellaDrug: Placebo
Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.
- Number of Participants With Pain Response [ Time Frame: Twelve Weeks ]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.
- Quality of Life ( IBS-QOL) [ Time Frame: Six Weeks ]After six weeks of treatment with Milnacipran, treatment groups were compared with placebo for clinically significant improvement in IBS-QOL. 11 point reduction in IBS-QOL compared to baseline was considered as clinically significant improvement.
- Subject Self Reported Adequate Relief of Pain [ Time Frame: Twelve Weeks ]The study sought to determine if the Milnacipran arms had a greater proportion of adequate relief over the placebo group. Subjects were asked to answer 'yes' or 'no' as to whether or not they had adequate relief of pain due to irritable bowel syndrome.
- Treatment Efficacy Questionnaire (TEQ) [ Time Frame: Twelve Weeks ]Treatment Efficacy Questionnaire is a measure of treatment effectiveness. The score ranges from 1 to 48, 1 is minimum score and 48 is the maximum score. The investigators was looking to see if the Milnacipran treatment groups have a higher proportion of subjects with significant improvement in efficacy, judged as a TEQ score of >28, compared to placebo group.
- Dose Related Incremental Benefit in Pain Reduction Based on VAS [ Time Frame: 12 Weeks ]The investigator was looking to see if, for group A, when increased from 50 mg BID to 100 mg BID there is significant improvement of pain scores i.e. 30% pain reduction, and for group C, if there was significant improvement of pain scores when switched from placebo to 50 mg BID of Milnacipran
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471379
|United States, North Carolina|
|UNC Center for Functional GI and Motility Disorders|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Spencer D Dorn, MD, MPH||University of North Carolina, Chapel Hill|