|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00727649 |
Purpose
The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.
| Condition | Intervention | Phase |
|---|---|---|
|
Fecal Incontinence |
Drug: Psyllium powder Drug: Loperamide |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence |
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
Fiber (psyllium) powder
|
Drug: Psyllium powder
2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)
|
|
3: Active Comparator
Loperamide
|
Drug: Loperamide
1 capsule daily for 28 days (weekly adjusted dose)
|
Fecal incontinence (FI) affects 4-24% adults in the community and greatly impacts quality of life. Both fiber and loperamide are common, first-line treatments for diarrhea-associated FI in primary care. No known studies exist that compare fiber and loperamide for diarrhea-predominant FI. Further knowledge is needed to define which treatment is more effective and to compare drug tolerability (side effects) for FI. This study will also look at changes in quality of life with treatment and potential mechanisms of drug treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Alayne Markland, DO MSc | (205) 933-8101 | alayne.markland@va.gov |
| Contact: Patricia S Goode, MD MSN BSN | (205) 933-3101 ext 7306 | patricia.goode@va.gov |
| United States, Alabama | |
| VA Medical Center, Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Alayne Markland, DO MSc 205-933-8101 alayne.markland@va.gov | |
| Principal Investigator: Alayne Markland, DO MSc | |
| Principal Investigator: | Alayne Markland, DO MSc | VA Medical Center, Birmingham |
More Information
| Responsible Party: | Department of Veterans Affairs ( Markland, Alayne - Principal Investigator ) |
| Study ID Numbers: | B6126W |
| Study First Received: | July 29, 2008 |
| Last Updated: | August 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00727649 |
| Health Authority: | United States: Federal Government |
|
fecal incontinence adults diarrhea |
|
Fecal Incontinence Diarrhea Gastrointestinal Diseases Urination Disorders Loperamide Intestinal Diseases Calcium polycarbophil |
Rectal Diseases Signs and Symptoms Digestive System Diseases Urologic Diseases Urinary Incontinence Psyllium |
|
Urological Manifestations Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions Antidiarrheals |
