Status:
COMPLETED
Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Irritable Bowel Syndrome
Constipation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Irritable bowel syndrome (IBS) is a common disorder which presents with abdominal pain or discomfort in association with altered bowel habit. IBS is further subcategorized as three types according to ...
Eligibility Criteria
Inclusion
- Males or females \>18 years of age
- Meet Rome III criteria for IBS\[2\]:
- Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with 2 or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency
- Onset associated with a change in form (appearance) of stool
- \*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
- Fulfill the Rome III stool consistency criteria for IBS-C\[2\]
- Hard or lumpy stools for \>25% of bowel movements
- Loose (mushy) or watery stools for \<25% of bowel movements
- Capable of independently completing all requirements of the study including returning for required visits
- Able to provide written informed consent for study participation
- Willing to discontinue prohibited medications during study participation
- Documentation of a normal colonoscopy within last 5 years if over age 50 years (or sigmoidoscopy if less than age 50)
- Documentation of normal thyroid stimulating hormone(TSH) level, complet blood count (CBC) and electrolyte panel within prior 3 years
- Females of childbearing potential must have a negative urine or serum pregnancy test at screening
- Females of childbearing potential must use an effective means of contraception during the course of the study
- Hormonal (oral, injectable, implantable, cervical/vaginal rings or patches)
- Double-barrier (condoms and/or diaphragm with spermicides) or intrauterine devices provided under the care of a health care professional
- Abstinence, in this case documentation of counseling will be recorded
Exclusion
- Unable to understand or provide written informed consent
- Pregnant or nursing
- Patients with IBS-D, IBS-M or unsubtyped IBS by Rome III criteria\[2\]
- IBS with diarrhea (IBS-D)
- Loose (mushy) or watery stools for \>25% of bowel movements
- Hard or lumpy stools for \<25% of bowel movements
- Mixed IBS (IBS-M)
- Hard or lumpy stools \>25% of bowel movements
- Loose (mushy) or watery stools for \>25% of bowel movements
- Unsubtyped IBS
- 1\. Insufficient abnormality of stool pattern to meet criteria for IBS-C, IBS-D or IBS-M
- Documented allergy or intolerance to lubiprostone
- Failure of balloon expulsion test
- Inability to expel 50cc balloon within 1 minute
- Use of drugs known to affect gastrointestinal motility
- Laxatives (stable doses of fiber taken for minimum of 4 weeks will be allowed)
- Osmotic laxatives:
- Magnesium hydroxide, Polyethylene glycol,Lactulose, Sorbitol
- Stimulant laxatives:
- Bisacodyl, Anthraquinones (senna), Misoprostol
- Prokinetic agents:
- Metoclopramide, domperidone, erythromycin
- Anti-diarrheal agents:
- Loperamide, Diphenoxylate, Bismuth
- Anti-spasmotics:
- Dicyclomine, Hyoscyamine
- Opioid, narcotic, opioid/narcotic-containing analgesics:
- Morphine, Hydrocodone, Codeine, Methadone, Propoxyphene
- Probiotics
- Systemic antibiotics within last 3 months
- Recently initiated antidepressants (stable dose for \>2 months for non-GI conditions will be allowed)
- Benzodiazepines \* Subjects taking prohibited medications will be required to stop these at the screening visit and remain off of them until completion of the study.
- Initiation of dietary changes potentially altering bowel transit within 4 weeks
- Comorbid medical problems that may affect gastrointestinal transit or motility
- Previous surgery involving the stomach, small bowel or colon (prior appendectomy, cholecystectomy, polypectomy allowed)
- Previous history of small bowel obstruction for any reason
- History of any gastrointestinal malignancy
- History of dyssynergic defecation
- Unexplained nausea and vomiting
- History of inflammatory bowel disease (Crohn's or ulcerative colitis)
- History of microscopic colitis (lymphocytic or collagenous colitis)
- History of Hirschsprung's disease
- Severe or complicated diverticular disease
- Chronic pancreatitis
- History of celiac disease
- History of eating disorders (anorexia nervosa or bulimia)
- Cirrhosis
- Chronic hepatitis B or C infection
- HIV infection
- Diabetes
- Systemic sclerosis (scleroderma)
- Amyloidosis
- Untreated thyroid disease
- Chronic pulmonary disease
- Severe renal insufficiency or renal failure
- Current or recent history (within last 6 months) of:
- Diverticulitis, Duodenal or gastric ulcer, Acute pancreatitis, Ileus
- Contraindications to SmartPill® (in addition to above):
- Cardiac pacemaker, defibrillator, or other implanted electromagnetic device, Known Zenker's diverticulum, Dysphagia
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01162863
Start Date
November 1 2010
End Date
December 1 2012
Last Update
January 27 2017
Active Locations (1)
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1
University of Michigan Health System
Ann Arbor, Michigan, United States, 48103