Irritable Bowel SyndromePhase 4NCT00961298
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
A Phase 4 study testing Duloxetine in people with Irritable Bowel Syndrome and Generalized Anxiety Disorder, run by West Penn Allegheny Health System.
Trial summary
The investigators propose to evaluate the effectiveness of duloxetine in treating subjects with both Irritable Bowel Syndrome (IBS) and Generalized Anxiety Disorder (GAD). The investigators hypothesize that duloxetine as a single therapeutic agent will effectively target pain and other core symptoms of IBS as well as… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome, Generalized Anxiety Disorder
- What is being tested?
- Duloxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Dec 2011
- 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
- Active IBS diagnosis by a gastroenterologist
- Generalized Anxiety Disorder diagnosed by DSM-IV TR criteria and the Mini International Neuropsychiatric Interview for the DSM-IV (Mini)
- No changes in any non study medication once starting the study
Who cannot join
- Current diagnoses of Major Depressive Disorder, Panic Disorder, Social Phobia, Post Traumatic Stress Disorder, Obsessive Compulsive Disorders, Eating Disorders, Somatoform Disorders, Drug or alcohol abuse or dependence, or severe personality disorder
- Lifetime history of any Bipolar Disorder or Psychotic Disorder
- Concurrent GI disorders falling outside of Rome III Functional GI disorders
- Pregnant women or sexually active female subjects not using medically acceptable method of contraception
- Current suicidal ideation
- Unstable medical condition
About this study
The investigators propose to evaluate the effectiveness of duloxetine in treating subjects with both Irritable Bowel Syndrome (IBS) and Generalized Anxiety Disorder (GAD). The investigators hypothesize that duloxetine as a single therapeutic agent will effectively target pain and other core symptoms of IBS as well as GAD in this patient population with both conditions.
Read the detailed description
Generalized Anxiety Disorder (GAD) is commonly associated with Irritable Bowel Syndrome(IBS). The etiology of IBS remains unknown and it is often refractory to treatment. Duloxetine has demonstrated efficacy in the treatment of GAD as well as other pain disorders including fibromyalgia and diabetic neuropathy.
We plan to study 30 subjects with diagnoses of IBS and GAD between the ages of 18 and 65 years. There will be a single-blind placebo-run-in for the first 2 weeks, followed by open-label duloxetine for 12 weeks flexibly titrated to 120 mg/day. Subjects will be informed that they will receive placebo for 2 weeks during the trial. All study visits will be at Allegheny General Hospital Department of Psychiatry. The study consists of a total of nine office visits.
- Being tested
- Duloxetine
- Keywords
- IBS, Irritable Bowel Syndrome, GAD, Generalized Anxiety Disorder
- Medical subject headings
- Irritable Bowel Syndrome, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
All subjects will receive single-blind placebo for the first two weeks, and then duloxetine for the next 12 weeks, followed by an up to 2 week taper off of the duloxetine. After 2 weeks of placebo daily, subjects will receive 30 mg per day of duloxetine for two weeks, then titrated up to 60 mg per day of duloxetine at week 2. A dosage decrease to 30 mg daily is permittable after week 2. This will be a flexible dose study with doses of duloxetine progressively increasing at weeks 4 (90 mg daily) and 6 (120 mg daily) in conjunction with CGI-I scores, to reach 120 mg daily or the maximum tolerated dose, if less than 120 mg daily at Week 12. There will be a post-taper follow up appointment at Week 14. Of Note: Amendment IRB Approved 6/14/11 Study Ending at Week 12 with removal of Week 14 visit as part of study.
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Two weeks of placebo run in followed by 12 weeks of Duloxetine. Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression Scale
The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale.
The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 "very much improved", 4 "no change", and 7 "very much worse."
Measured: endpoint [12 weeks]
Secondary outcomes (3)
Hamilton Anxiety Rating Scale
The HAM-A is a 14 question scale with five responses. Responses range from 0 "not present" to 4 "very severe." The total score ranges from 0 to 56. Higher values represent a worse outcome.
Measured: endpoint [12 weeks]
Irritable Bowel Syndrome-Quality of Life Scale
The IBS-QOL consists of 34 items, each with a five-point response scale. Ratings range from 1 "not at all" to 5 "extremely" or "a great deal" Higher responses on the scale indicate worse outcome. A minimal total score would be 34, maximum 170.
Measured: endpoint [12 weeks]
Irritable Bowel Syndrome Severity Scoring System
This is a 4 item Likert scale with each assessment being 100 mm scored from measuring from 0 to 400. Higher numbers indicate worse outcome.
Measured: endpoint [12 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionDec 2011
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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Penn Allegheny Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alicia Kaplan, West Penn Allegheny Health System
- Investigators
- Alicia J Kaplan, MD, Principal investigator, West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961298
- Sponsor's protocol ID
- RC-4656
- Status last verified
- Jun 2014
- First submitted
- 17 Aug 2009
- Last updated
- 9 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kaplan A, Franzen MD, Nickell PV, Ransom D, Lebovitz PJ. An open-label trial of duloxetine in patients with irritable bowel syndrome and comorbid generalized anxiety disorder. Int J Psychiatry Clin Pract. 2014 Jan;18(1):11-5. doi: 10.3109/13651501.2013.838632. Epub 2013 Sep 20.
PubMed 23980534
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00961298
- Acronym / sponsor ID
- RC-4656
- Keywords
- IBS, Irritable Bowel Syndrome, GAD, Generalized Anxiety Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- West Penn Allegheny Health SystemUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Posted 9 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to evaluate the effectiveness of duloxetine in treating subjects with both Irritable Bowel Syndrome (IBS) and Generalized Anxiety Disorder (GAD). The investigators hypothesize that duloxetine as a single therapeutic agent will effectively target pain and other core symptoms of IBS as well as GAD in this patient population with both conditions.
Detailed description
Generalized Anxiety Disorder (GAD) is commonly associated with Irritable Bowel Syndrome(IBS). The etiology of IBS remains unknown and it is often refractory to treatment. Duloxetine has demonstrated efficacy in the treatment of GAD as well as other pain disorders including fibromyalgia and diabetic neuropathy.
We plan to study 30 subjects with diagnoses of IBS and GAD between the ages of 18 and 65 years. There will be a single-blind placebo-run-in for the first 2 weeks, followed by open-label duloxetine for 12 weeks flexibly titrated to 120 mg/day. Subjects will be informed that they will receive placebo for 2 weeks during the trial. All study visits will be at Allegheny General Hospital Department of Psychiatry. The study consists of a total of nine office visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: DuloxetineTwo weeks of placebo run in followed by 12 weeks of Duloxetine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years of age
- Active IBS diagnosis by a gastroenterologist
- Generalized Anxiety Disorder diagnosed by DSM-IV TR criteria and the Mini International Neuropsychiatric Interview for the DSM-IV (Mini)
- No changes in any non study medication once starting the study
Key exclusion criteria (6 listed)
- Current diagnoses of Major Depressive Disorder, Panic Disorder, Social Phobia, Post Traumatic Stress Disorder, Obsessive Compulsive Disorders, Eating Disorders, Somatoform Disorders, Drug or alcohol abuse or dependence, or severe personality disorder
- Lifetime history of any Bipolar Disorder or Psychotic Disorder
- Concurrent GI disorders falling outside of Rome III Functional GI disorders
- Pregnant women or sexually active female subjects not using medically acceptable method of contraception
- Current suicidal ideation
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: CymbaltaAll subjects will receive single-blind placebo for the first two weeks, and then duloxetine for the next 12 weeks, followed by an up to 2 week taper off of the duloxetine. After 2 weeks of placebo daily, subjects will receive 30 mg per day of duloxetine for two weeks, then titrated up to 60 mg per day of duloxetine at week 2. A dosage decrease to 30 mg daily is permittable after week 2. This will be a flexible dose study with doses of duloxetine progressively increasing at weeks 4 (90 mg daily) and 6 (120 mg daily) in conjunction with CGI-I scores, to reach 120 mg daily or the maximum tolerated dose, if less than 120 mg daily at Week 12. There will be a post-taper follow up appointment at Week 14. Of Note: Amendment IRB Approved 6/14/11 Study Ending at Week 12 with removal of Week 14 visit as part of study. | Drug | Duloxetine |
Primary outcome
Clinical Global Impression Scale
Time frame: endpoint [12 weeks]
The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale. The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 "very much improved", 4 "no change", and 7 "very much worse."
3 secondary outcomes
Hamilton Anxiety Rating Scale
Time frame: endpoint [12 weeks]
Irritable Bowel Syndrome-Quality of Life Scale
Time frame: endpoint [12 weeks]
Irritable Bowel Syndrome Severity Scoring System
Time frame: endpoint [12 weeks]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23980534Kaplan A, Franzen MD, Nickell PV, Ransom D, Lebovitz PJ. An open-label trial of duloxetine in patients with irritable bowel syndrome and comorbid generalized anxiety disorder. Int J Psychiatry Clin Pract. 2014 Jan;18(1):11-5. doi: 10.3109/13651501.2013.838632. Epub 2013 Sep 20.
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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.
Alicia J Kaplan, MD principal investigator
West Penn Allegheny Health System
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine in people with Irritable Bowel Syndrome and Generalized Anxiety Disorder, run by West Penn Allegheny Health System.
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 6 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 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 9 Jul 2014). 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?
Clinical Global Impression Scale (time frame: endpoint [12 weeks]). 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 NCT00961298, 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 Jul 2014.