N/A
N=9
Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis
Constipation · Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00706004 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Number of Spontaneous Bowel Movements Per Week — 9.7; 10.8; 8.8 bowel movements
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- lubiprostone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Spontaneous Bowel Movements Per Week |
9.7; 10.8; 8.8 | — |
| SECONDARY Patient Assessment of Constipation Symptoms |
1.18; 0.54; 0.44 | — |
| SECONDARY Bristol Stool Scale Score |
3.4; 3.6; 3.3 | — |
| SECONDARY Body Mass Index |
24.0; 24.0; 24.3 | — |
| SECONDARY Self Reported Adverse Effects at Each Study Visit |
5; 3 | — |
| SECONDARY Serum Sodium |
137.4; 139.2 | — |
| SECONDARY Serum Chloride |
103.0; 104.3 | — |
| SECONDARY Serum Potassium |
4.4; 4.4 | — |
| SECONDARY Serum Bicarb |
23.8; 25.2 | — |
| SECONDARY Serum BUN |
13.0; 12.7 | — |
| SECONDARY Serum Creatinine |
0.79; 0.84 | — |
| SECONDARY AST |
20.6; 17.5 | — |
| SECONDARY ALT |
25.1; 23.8 | — |
| SECONDARY Serum Calcium |
9.3; 9.3 | — |
| SECONDARY Serum Magnesium |
2.0; 2.0 | — |
| SECONDARY Serum Phosphate |
3.8; 3.7 | — |
| SECONDARY Serum Glucose |
150.3; 131.8 | — |
| SECONDARY Serum Vitamin D |
25.3; 25.3 | — |
| SECONDARY Serum Vitamin A |
41.3; 42.7 | — |
| SECONDARY Serum Vitamin E |
6.6; 7.7 | — |
| SECONDARY Serum Prealbumin |
22.6; 21.5 | — |
| SECONDARY Serum Albumin |
4.3; 4.3 | — |
Summary
The purpose of this study is to determine the short term safety and effectiveness of lubiprostone when used for constipation in adults with cystic fibrosis.
Eligibility Criteria
Inclusion Criteria
- Men and women of all races
- 18 years of age or older at time of enrollment
- Diagnosis of cystic fibrosis
- History of constipation, as defined by the Rome III criteria, OR the requirement of chronic scheduled doses of a laxative, OR a score ≥1.5 on the Patient assessment of constipation symptoms (PAC-SYM)15 survey administered during the screening visit, OR a score of less than 3 on the Bristol Stool Scale (BSS) at the screening visit.
Exclusion Criteria
- Current gastrointestinal (GI) obstruction
- History of GI obstruction requiring hospitalization within six months of enrollment
- Pregnancy or breastfeeding
- Hypersensitivity to lubiprostone or any of its components
- Serum creatinine >1.8 mg/dL at last annual visit
- Clinically significant liver disease, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3X upper limit of normal
- History of frequent hospital admissions for CF exacerbations (≥4 in the last 6 months)
- Currently registered on a lung transplant waiting list
- Women of capable of child-bearing who either refuse a pregnancy test, or are incapable or unwilling to use contraception during the protocol, or both.
- Any other condition, in the opinion of the investigators, that interferes with the ability of the participant to comply with study requirements, confers significant risk to the participant, or limits the ability of the participant to complete the study
Data sourced from ClinicalTrials.gov (NCT00706004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.