A Phase 2 interventional study of Milnacipran and Milnacipran in Irritable Bowel Syndrome, sponsored by Spencer Dorn, MD, MPH. Terminated at 1 site in United States. Open to female participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2017-04-13.
Sponsored by Spencer Dorn, MD, MPH · Phase 2, Interventional, and Treatment
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 2 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →This is the only study on the registry with Spencer Dorn, MD, MPH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II
Drug: Milnacipran · Drug: Placebo
50mg Milnacipran PO, BID, for 6 weeks.
Also known as: Savella
Milnacipran, 100mg PO, BID, for six weeks
Also known as: Savella
Milnacipran, 50mg PO BID for 12 weeks
Also known as: Savella
Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.
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.
Time frame: Twelve Weeks
Quality of Life ( IBS-QOL)
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.
Time frame: Six Weeks
Subject Self Reported Adequate Relief of Pain
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.
Time frame: Twelve Weeks
Treatment Efficacy Questionnaire (TEQ)
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.
Time frame: Twelve Weeks
Dose Related Incremental Benefit in Pain Reduction Based on VAS
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
Time frame: 12 Weeks
The subjects were recruited from community using University of North Carolina (UNC) mass email system, newspaper advertisement and UNC gastrointestinal (GI) clinic referral.
| Milestone | Group A (50mg - 100mg) | Group B (50mg x12) | Group C (Placebo - 50mg) |
|---|---|---|---|
| Started | 1 | 1 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 1 | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Study terminated | 0 | 1 | 0 |
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.
| participants | Group A (50mg - 100mg) | Group B (50mg x12) | Group C (Placebo - 50mg) |
|---|---|---|---|
| Number of Participants With Pain Response | 0 | — | — |
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.
No measurements were reported for this outcome.
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.
| percentage of participants | Group A (50mg - 100mg) | Group B (50mg x12) | Group C (Placebo - 50mg) |
|---|---|---|---|
| Subject Self Reported Adequate Relief of Pain | 0 | — | — |
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.
| percentage of subject with score >28 | Group A (50mg - 100mg) | Group B (50mg x12) | Group C (Placebo - 50mg) |
|---|---|---|---|
| Treatment Efficacy Questionnaire (TEQ) | 0 | — | — |
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
| percentage of participants | Group A (50mg - 100mg) | Group B (50mg x12) | Group C (Placebo - 50mg) |
|---|---|---|---|
| Dose Related Incremental Benefit in Pain Reduction Based on VAS | 0 | — | — |
Collected over 3 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A (50mg - 100mg) | — | 0/1 (0%) | 1/1 (100%) |
| Group B (50mg x12) | — | 0/1 (0%) | — |
| Group C (Placebo - 50mg) | — | — | — |
| Event | Group A (50mg - 100mg) | Group B (50mg x12) | Group C (Placebo - 50mg) |
|---|---|---|---|
| hypertensionCardiac disorders | 1/1 | — | — |
The study was terminated early resulting in a small number of subjects enrolled leaving the ability to analyze only certain categories.
| Age, Categorical(Participants) | Group A (50mg - 100mg) | Group B (50mg x12) | Group C (Placebo - 50mg) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | — | 0 |
| Between 18 and 65 years | 1 | 1 | — | 2 |
| >=65 years | 0 | 0 | — | 0 |
| Age, Continuous(years) | Group A (50mg - 100mg) | Group B (50mg x12) | Group C (Placebo - 50mg) | Total |
|---|---|---|---|---|
| Mean | 47 ± 0 | 66 ± 0 | — | 56.5 ± 9.5 |
| Sex: Female, Male(Participants) | Group A (50mg - 100mg) | Group B (50mg x12) | Group C (Placebo - 50mg) | Total |
|---|---|---|---|---|
| Female | 1 | 1 | — | 2 |
| Male | 0 | 0 | — | 0 |
| Region of Enrollment(participants) | Group A (50mg - 100mg) | Group B (50mg x12) | Group C (Placebo - 50mg) | Total |
|---|---|---|---|---|
| United States | 1 | 1 | — | 2 |
This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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