Irritable Bowel SyndromePhase 3NCT00006157
Treatment of Functional Bowel Disorders
A Phase 3 study testing Desipramine and Cognitive Behavioral Treatment in people with Irritable Bowel Syndrome and Constipation, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites in 2 countries.
Trial summary
The primary purpose for this study is to compare clinical treatments for patients with functional bowel disorders (irritable bowel syndrome, abdominal pain, painful constipation) in women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome, Constipation, Abdominal Pain
- What is being tested?
- Desipramine and Cognitive Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 1996to Mar 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Literate, female patients aged 18-65.
- Symptoms present at least 2 days/week for greater than 6 months.
- Diagnosis of functional bowel disorder (to be subcategorized using ''Rome'' Criteria.
- Moderate (MFBD) or severe (SFBD) functional bowel disorder (FBD) based on the Functional Bowel Disorder Severity Index (FBDSI) developed in our pilot study. SFBD will be defined as a score of 110 and MFBD will be defined as a score between 36 and 110.
- Discontinuation of all antidepressant medications for at least 3 months.
- Use of acceptable method of birth control.
Who cannot join
- Evidence of lactose intolerance to explain bowel symptoms.
- Heart disease.
- Cardiac arrhythmias.
- Severe psychiatric disorder (e.g., bipolar, suicide attempts).
- Previous use of desipramine.
- Glaucoma.
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- Urinary retention.
- Pregnancy.
- Alcohol consumption 3oz/day that would preclude participation or prevent data assessment.
- Systemic gastrointestinal diseases or previous surgery that would interfere with the interpretation of symptoms or physiology.
- Bipolar disorder.
- Schizophrenia.
- Substance abuse/dependency.
- Previous use of desipramine.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
UNC Center for Functional GI Motility Disorders
Chapel Hill, North Carolina, 27599-7080
Canada1 site
Centre for Addiction and Mental Health, Clark Site
Toronto, Ontario, M5T 1R8
About this study
Official title: Multicenter Trial of Functional Bowel Disorders
The primary purpose for this study is to compare clinical treatments for patients with functional bowel disorders (irritable bowel syndrome, abdominal pain, painful constipation) in women. We also plan to: 1) determine what clinical features (medical or psychological) determine which patients will improve to these treatments, and 2) understand if there are any physiological features that relate to improvement in symptoms and response to the treatments.
We will compare a psychological treatment (cognitive-behavioral therapy - CBT) with education/attention placebo, and an antidepressant drug (desipramine) with a pill placebo. This is the first large-scale study designed to determine the therapeutic effects of these methods, and to also determine interactions among physiologic measures, psychologic and sociodemographic factors, severity of symptoms, and therapeutic improvement including quality of life.
Read the detailed description
Female patients (aged 18-65) with FBD (irritable bowel syndrome, painful constipation and/or functional abdominal pain) will be enrolled at UNC-Chapel Hill and Toronto, Canada. A severity index will determine recruitment into the group of moderate FBD (200 patients) and severe FBD (100 patients). Each group will be randomized into the three treatment arms (cognitive-behavioral treatment, desipramine, and education/attention placebo), treated over a 12-week period, and followed for one year. Outcome measures will include symptoms (standardized abdominal pain, stool form and frequency) using diary cards, daily functional status (Sickness Impact Profile), depression (HAM-D) and psychological distress (SCL-90), physiological measures (enhanced rectal motility and visceral sensation), and health care use. Multivariate statistical methods with a hierarchical design will be applied to the data to assure maintenance of statistical power over multiple tests of overlapping groups.
The results of this study should significantly improve our understanding of this complicated syndrome that lowers the quality of life and economic productivity of large numbers of women. The clinical impact of the study, in providing physicians with scientific evidence of the efficacy of treatments of FBD that are commonly used in practice, is significant. We anticipate that this study will provide clinicians with predictors of success among types of FBD patients and types of therapy that will improve symptoms and quality of life, and reduce the health care costs associated with this common syndrome while improving patient-physician satisfaction.
- Being tested
- Desipramine, Cognitive Behavioral Treatment
- Keywords
- Functional bowel disorder, Irritable bowel syndrome, Painful constipation, Unspecified functional bowel disorder, Chronic functional abdominal pain, Cognitive-behavioral psychological treatment, IBS, CFAP
- Medical subject headings
- Irritable Bowel Syndrome, Constipation, Abdominal Pain, Colonic Diseases, Functional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesipramineDrug
Cognitive Behavioral TreatmentBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2000 (estimated)
- Study startJul 1996
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Douglas A. Drossman, M.D., Principal investigator, Univ of North Carolina at Chapel HillWilliam E. Whitehead, PhD, Study chair, Univ of North Carolina at Chapel HillBrenda Toner, PhD, Study chair, Centre for Addiction and Mental Health, Clark SiteNick Diamant, MD, Study chair, The Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006157
- Sponsor's protocol ID
- FBD (completed)
- Other IDs
- R01DK049334
- Status last verified
- Jan 2010
- First submitted
- 8 Aug 2000
- Last updated
- 13 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial of Functional Bowel Disorders
- ClinicalTrials.gov ID
- NCT00006157
- Acronym / sponsor ID
- FBD (completed)
- Keywords
- Functional bowel disorder, Irritable bowel syndrome, Painful constipation, Unspecified functional bowel disorder, Chronic functional abdominal pain, Cognitive-behavioral psychological treatment, IBS, CFAP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jul 1996
- Study completion
- Mar 2001
- First posted
- 9 Aug 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose for this study is to compare clinical treatments for patients with functional bowel disorders (irritable bowel syndrome, abdominal pain, painful constipation) in women. We also plan to: 1) determine what clinical features (medical or psychological) determine which patients will improve to these treatments, and 2) understand if there are any physiological features that relate to improvement in symptoms and response to the treatments.
We will compare a psychological treatment (cognitive-behavioral therapy - CBT) with education/attention placebo, and an antidepressant drug (desipramine) with a pill placebo. This is the first large-scale study designed to determine the therapeutic effects of these methods, and to also determine interactions among physiologic measures, psychologic and sociodemographic factors, severity of symptoms, and therapeutic improvement including quality of life.
Detailed description
Female patients (aged 18-65) with FBD (irritable bowel syndrome, painful constipation and/or functional abdominal pain) will be enrolled at UNC-Chapel Hill and Toronto, Canada. A severity index will determine recruitment into the group of moderate FBD (200 patients) and severe FBD (100 patients). Each group will be randomized into the three treatment arms (cognitive-behavioral treatment, desipramine, and education/attention placebo), treated over a 12-week period, and followed for one year. Outcome measures will include symptoms (standardized abdominal pain, stool form and frequency) using diary cards, daily functional status (Sickness Impact Profile), depression (HAM-D) and psychological distress (SCL-90), physiological measures (enhanced rectal motility and visceral sensation), and health care use. Multivariate statistical methods with a hierarchical design will be applied to the data to assure maintenance of statistical power over multiple tests of overlapping groups.
The results of this study should significantly improve our understanding of this complicated syndrome that lowers the quality of life and economic productivity of large numbers of women. The clinical impact of the study, in providing physicians with scientific evidence of the efficacy of treatments of FBD that are commonly used in practice, is significant. We anticipate that this study will provide clinicians with predictors of success among types of FBD patients and types of therapy that will improve symptoms and quality of life, and reduce the health care costs associated with this common syndrome while improving patient-physician satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Literate, female patients aged 18-65.
- Symptoms present at least 2 days/week for greater than 6 months.
- Diagnosis of functional bowel disorder (to be subcategorized using ''Rome'' Criteria.
- Moderate (MFBD) or severe (SFBD) functional bowel disorder (FBD) based on the Functional Bowel Disorder Severity Index (FBDSI) developed in our pilot study. SFBD will be defined as a score of 110 and MFBD will be defined as a score between 36 and 110.
- Discontinuation of all antidepressant medications for at least 3 months.
Key exclusion criteria (14 listed)
- Evidence of lactose intolerance to explain bowel symptoms.
- Heart disease.
- Cardiac arrhythmias.
- Severe psychiatric disorder (e.g., bipolar, suicide attempts).
- Previous use of desipramine.
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 |
|---|---|---|
| Desipramine | Drug | – |
| Cognitive Behavioral Treatment | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- The website for the UNC Center for Functional GI and Motility Disorders contains information on our center, functional bowel disorders, current clinical trials, and other FBD resources.Link provided by the sponsor.
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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.
Douglas A. Drossman, M.D. principal investigator
Univ of North Carolina at Chapel Hill
William E. Whitehead, PhD study chair
Univ of North Carolina at Chapel Hill
Brenda Toner, PhD study chair
Centre for Addiction and Mental Health, Clark Site
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desipramine and Cognitive Behavioral Treatment in people with Irritable Bowel Syndrome and Constipation, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites in 2 countries.
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 6 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: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 Jan 2010.