Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006157
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2000-08-08
Brief Title:
Treatment of Functional Bowel Disorders
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Multicenter Trial of Functional Bowel Disorders
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 educationattention 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
We will compare a psychological treatment cognitive-behavioral therapy - CBT with educationattention 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 andor 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 educationattention 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK049334 | NIH | None | httpsreporternihgovquickSearchR01DK049334 |