Irritable Bowel SyndromePhase 2NCT01471379
Milnacipran (Savella) in Irritable Bowel Syndrome (IBS)
A Phase 2 study testing Milnacipran in people with Irritable Bowel Syndrome, run by Spencer Dorn, MD, MPH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Milnacipran
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Feb 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center for Functional GI and Motility Disorders
Chapel Hill, North Carolina, 27599
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Milnacipran in the Treatment of Irritable Bowel Syndrome
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.
Read the 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
- Being tested
- Milnacipran, Placebo
- Keywords
- Irritable Bowel Syndrome, IBS, Savella, Milnacipran, Abdominal Pain
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilnacipranDrug
Also called Savella
50mg Milnacipran PO, BID, for 6 weeks.
MilnacipranDrug
Also called Savella
Milnacipran, 100mg PO, BID, for six weeks
MilnacipranDrug
Also called Savella
Milnacipran, 50mg PO BID for 12 weeks
PlaceboDrug
Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Drug: Milnacipran; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twelve Weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startApr 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Due to recruitment difficulties the study is terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spencer Dorn, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor-investigator, Spencer Dorn, MD, MPH, University of North Carolina, Chapel Hill
- Investigators
- Spencer D Dorn, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471379
- Sponsor's protocol ID
- 11-1105a
- Status last verified
- Mar 2017
- First submitted
- 10 Nov 2011
- Last updated
- 13 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Milnacipran in the Treatment of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01471379
- Acronym / sponsor ID
- 11-1105a
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, IBS, Savella, Milnacipran, Abdominal Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to recruitment difficulties the study is terminated.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Spencer Dorn, MD, MPHUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Apr 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Posted 24 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (50mg - 100mg) | Experimental | Drug: MilnacipranGroup A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II |
| Group B (50mg x12) | Active comparator | Drug: MilnacipranSubjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study. |
| Group C (Placebo - 50mg) | Placebo comparator | Drug: Milnacipran, Drug: PlaceboGroup C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MilnacipranAlso: Savella50mg Milnacipran PO, BID, for 6 weeks. | Drug | Group A (50mg - 100mg), Group C (Placebo - 50mg) |
| MilnacipranAlso: SavellaMilnacipran, 100mg PO, BID, for six weeks | Drug | Group A (50mg - 100mg) |
| MilnacipranAlso: SavellaMilnacipran, 50mg PO BID for 12 weeks | Drug | Group B (50mg x12) |
| PlaceboInactive pill, identical in shape, size, and appearance to active drug, PO, BID. | Drug | Group C (Placebo - 50mg) |
Primary outcome
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.
4 secondary outcomes
Quality of Life ( IBS-QOL)
Time frame: Six Weeks
Subject Self Reported Adequate Relief of Pain
Time frame: Twelve Weeks
Treatment Efficacy Questionnaire (TEQ)
Time frame: Twelve Weeks
Dose Related Incremental Benefit in Pain Reduction Based on VAS
Time frame: 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Spencer D Dorn, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Milnacipran in people with Irritable Bowel Syndrome, run by Spencer Dorn, MD, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Pain Response (time frame: Twelve Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.