Irritable Bowel SyndromePhase 4NCT00401258
An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome
A Phase 4 study testing duloxetine in people with Irritable Bowel Syndrome, run by Mclean Hospital at 1 site in United States.
Trial summary
We hypothesize that duloxetine treatment will be associated with improvement in symptoms of IBS, particularly abdominal pain, in individuals without comorbid major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Feb 2008
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- Subjects must have been diagnosed with irritable bowel syndrome by a physician
- Subjects must have had gastrointestinal symptoms for 2 or more days per week for > 6 months
Who cannot join
- Lifetime history of bipolar disorder, psychotic disorder, or obsessive-compulsive disorder
- Current (within past 6 months) diagnosis of major depressive disorder or substance abuse disorder
- Active suicidal/homicidal ideation
- Pregnant women or women of child-bearing potential not using an approved methods of contraception
- Individuals with an unstable medical condition that in the opinion of the investigator would interfere with the interpretation of symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome Without Comorbid Major Depressive Disorder
We hypothesize that duloxetine treatment will be associated with improvement in symptoms of IBS, particularly abdominal pain, in individuals without comorbid major depressive disorder.
During this 12-week, open-label, outpatient study, male and female subjects between the ages of 18 and 65 years who have been diagnosed with irritable bowel syndrome (IBS) will be treated with open-label duloxetine.
Read the detailed description
IBS is a chronic gastrointestinal disorder characterized by abdominal pain, altered bowel habits, and abdominal bloating for which no organic cause can be determined. Duloxetine has demonstrated efficacy in the treatment of depression as well as in several pain syndromes including diabetic peripheral neuropathy and fibromyalgia. We hypothesize that it will be a safe and efficacious treatment for the symptoms of IBS, in particular abdominal pain.
We plan to study 15 male and female subjects between the ages of 18 and 65 years who have had gastrointestinal symptoms at least 2 days/week for greater than six months and who have been diagnosed with IBS by a physician. During the 12-week study, subjects will receive open-label duloxetine titrated up to 60mg/day. Subjects will be asked to complete a total of ten study visits during the 12-week study period. All study visits will be conducted at McLean Hospital.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- duloxetine
- Keywords
- IBS, irritable bowel syndrome, irritable bowel
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetineDrug
Also called Cymbalta
30mg oral duloxetine per day for one week, titrated up to 60mg per day at day 8, concluded by a one week taper period of 4 days of 30mg pills at the conclusion of the study, followed by 3 days on no medication (4+3 days=1 week), concluded with a post-taper follow-up appointment with a study physician.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | 12-week, open-label trial of duloxetine in subjects with IBS. Receives: Drug: duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994).
Subjects rated abdominal pain daily on a scale of 0-10 (0 being no pain and 10 being worst pain). The pain score at each visit represented the mean score from all days since the previous visit.
Measured: baseline and week 12
Secondary outcomes (7)
Brief Pain Inventory
The Brief Pain Inventory is a self-administered questionnaire used to evaluate the severity of a patient's pain and its interference with their life.
Four items measure pain severity on a scale of 0-10, with 0 being absence of pain and 10 being severe pain. Seven items measure pain interference on a scale of 0-10, with 0 being absence of interference and 10 being severe interference.
The sub scale of both sub scores ranges 0-40, with 0 indicating no pain/interference and 40 indicating severe pain/interference.
The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12.
Measured: At each visit
Short Form McGill Pain Questionnaire
The Short Form McGill Pain Questionnaire is a self-administered questionnaire that measures pain intensity experienced by the patient. Scores on 15 descriptors are rated on an intensity scale of 0-3 (with 0 being no pain to 3 being severe pain), and has an overall score of between 0-45, with 0 being no pain and 45 being worst possible pain.
The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12.
Measured: At each visit
Clinical Global Impression Scale
The Clinical Global Impression Scale is a clinician-rated scale that evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12.
Measured: At each visit
Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale is a clinician-rated scale consisting of 17 questions designed to assess depressive symptoms. Scores of 0-7 are considered normal, 8-16 suggest mild depression, 17-23 moderate depression, and scores over 24 are indicative of severe depression. 52 is the maximum score.
Measured: At first visit only
Hamilton Anxiety Rating Scale
The Hamilton Anxiety Rating Scale is a clinician-administered scale designed to assess the severity of symptoms of anxiety. There are 14 items, scored on a scale of 0 (not present) to 4 (severe). The total score range is 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe.
The primary analysis of this scale was an endpoint analysis of the change from baseline.
Measured: At baseline and week 12
Irritable Bowel Syndrome-Quality of Life Scale
The Irritable Bowel Syndrome (IBS) Quality of Life Scale is a self-report quality of life measure specific to Irritable Bowel Syndrome that can be used to assess the impact of IBS and its treatment. There are 34 items summed and averaged for a total score between 0-100, with higher scores indicating better IBS specific quality of life.
Each item measures one of eight sub scales - dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationships - and is rated on a scale of 1-5 indicating how much the subject agrees with the statement (1 is no agreement, 5 is extreme agreement).
The primary analysis of this scale was an endpoint analysis of the change from baseline.
Measured: At baseline and week 12
Sheehan Disability Scale
The Sheehan Disability Scale is a brief, 5-item self-report tool that assess functional impairment in work/school, social life, and family life. Scores range from 0-10 in each subset, with 0 being unimpaired and 10 being highly impaired.
The primary analysis of this scale was an endpoint analysis of the change from baseline.
Measured: At baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionFeb 2008
- Study completionFeb 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Brian P. Brennan, MD, Mclean Hospital
- Investigators
- Brian P Brennan, MD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401258
- Sponsor's protocol ID
- 2006-P-001723
- Status last verified
- Feb 2018
- First submitted
- 16 Nov 2006
- Last updated
- 9 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Brennan BP, Fogarty KV, Roberts JL, Reynolds KA, Pope HG Jr, Hudson JI. Duloxetine in the treatment of irritable bowel syndrome: an open-label pilot study. Hum Psychopharmacol. 2009 Jul;24(5):423-8. doi: 10.1002/hup.1038.
PubMed 19548294
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome Without Comorbid Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00401258
- Acronym / sponsor ID
- 2006-P-001723
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, irritable bowel syndrome, irritable bowel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Nov 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 20 Nov 2006 (estimated)
- Results
- Posted 27 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that duloxetine treatment will be associated with improvement in symptoms of IBS, particularly abdominal pain, in individuals without comorbid major depressive disorder.
During this 12-week, open-label, outpatient study, male and female subjects between the ages of 18 and 65 years who have been diagnosed with irritable bowel syndrome (IBS) will be treated with open-label duloxetine.
Detailed description
IBS is a chronic gastrointestinal disorder characterized by abdominal pain, altered bowel habits, and abdominal bloating for which no organic cause can be determined. Duloxetine has demonstrated efficacy in the treatment of depression as well as in several pain syndromes including diabetic peripheral neuropathy and fibromyalgia. We hypothesize that it will be a safe and efficacious treatment for the symptoms of IBS, in particular abdominal pain.
We plan to study 15 male and female subjects between the ages of 18 and 65 years who have had gastrointestinal symptoms at least 2 days/week for greater than six months and who have been diagnosed with IBS by a physician. During the 12-week study, subjects will receive open-label duloxetine titrated up to 60mg/day. Subjects will be asked to complete a total of ten study visits during the 12-week study period. All study visits will be conducted at McLean Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: duloxetine12-week, open-label trial of duloxetine in subjects with IBS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years of age
- Subjects must have been diagnosed with irritable bowel syndrome by a physician
- Subjects must have had gastrointestinal symptoms for 2 or more days per week for > 6 months
Key exclusion criteria (5 listed)
- Lifetime history of bipolar disorder, psychotic disorder, or obsessive-compulsive disorder
- Current (within past 6 months) diagnosis of major depressive disorder or substance abuse disorder
- Active suicidal/homicidal ideation
- Pregnant women or women of child-bearing potential not using an approved methods of contraception
- Individuals with an unstable medical condition that in the opinion of the investigator would interfere with the interpretation of symptoms
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 |
|---|---|---|
| duloxetineAlso: Cymbalta30mg oral duloxetine per day for one week, titrated up to 60mg per day at day 8, concluded by a one week taper period of 4 days of 30mg pills at the conclusion of the study, followed by 3 days on no medication (4+3 days=1 week), concluded with a post-taper follow-up appointment with a study physician. | Drug | 1 |
Primary outcome
Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994).
Time frame: baseline and week 12
Subjects rated abdominal pain daily on a scale of 0-10 (0 being no pain and 10 being worst pain). The pain score at each visit represented the mean score from all days since the previous visit.
7 secondary outcomes
Brief Pain Inventory
Time frame: At each visit
Short Form McGill Pain Questionnaire
Time frame: At each visit
Clinical Global Impression Scale
Time frame: At each visit
Hamilton Depression Rating Scale
Time frame: At first visit only
Hamilton Anxiety Rating Scale
Time frame: At baseline and week 12
Irritable Bowel Syndrome-Quality of Life Scale
Time frame: At baseline and week 12
Sheehan Disability Scale
Time frame: At baseline and week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19548294Brennan BP, Fogarty KV, Roberts JL, Reynolds KA, Pope HG Jr, Hudson JI. Duloxetine in the treatment of irritable bowel syndrome: an open-label pilot study. Hum Psychopharmacol. 2009 Jul;24(5):423-8. doi: 10.1002/hup.1038.
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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.
Brian P Brennan, MD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing duloxetine in people with Irritable Bowel Syndrome, run by Mclean Hospital 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Mar 2018. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 27 Aug 2010). 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?
Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994). (time frame: baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00401258, which also lists 1 linked publication.
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 9 Mar 2018.