ConstipationNCT00706004
Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis
A study testing lubiprostone in people with Constipation and Cystic Fibrosis, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Cystic Fibrosis
- What is being tested?
- lubiprostone
- Type of treatment
- Pill or oral medicine
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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.
Read the detailed description
Cystic fibrosis (CF) affects about 30,000 people in the United States. It is caused by an absent or dysfunctional protein called CF transmembrane conductance regulator (CFTR) which functions as a chloride channel. Lubiprostone is a medication indicated for constipation that activates type 2 chloride channels (ClC-2) and has the potential to be an effective treatment for constipation in adults with CF. It has the potential to correct the underlying disorder by utilizing a chloride channel whose activity does not depend on CFTR. This project is a prospective open-label pilot study to examine the safety and effectiveness of lubiprostone when used in adults with CF with constipation. The specific aims are as follows: 1) Determine the effectiveness of lubiprostone for constipation in participants with CF, and 2) Determine the short term safety of lubiprostone in adults with CF. Data will also be collected to generate further information about the effect of lubiprostone on nutritional status.
- Conditions
- Constipation, Cystic Fibrosis
- Being tested
- lubiprostone
- Keywords
- constipation, cystic fibrosis, lubiprostone, Constipation in adults with cystic fibrosis
- Medical subject headings
- Constipation, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lubiprostoneDrug
Also called Brand name: Amitiza
lubiprostone 24 microgram capsule taken twice daily for 4 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Spontaneous Bowel Movements Per Week
Measured: 2-week run-in period, 2-weeks of treatment, 4-weeks of treatment
Secondary outcomes (21)
Patient Assessment of Constipation Symptoms
The Patient Assessment of Constipation - Symptom (PAC-SYM) survey is a 1-page 12-item tool that measures a patient's assessment of constipation symptoms. The items are in Likert scale format and address the severity of stool, rectal and abdominal symptoms over the past 2 weeks. Items are scored on a scale of 0 to 4, with 4 indicating the most severe. To compute the overall score, the scores of the non-missing items are summed and this is divided by the total number of non-missing items (overall score range, 0 to 4).
Measured: 2-week run-in period, 2 weeks of treatment, 4 weeks of treatment
Bristol Stool Scale Score
The Bristol Stool Scale is a scale used to rate the consistency of stool. Stool types are accompanied by a written description. There are seven types of stool that are scored from 1 to 7. A score of 1 or 2 indicates constipation; a score of 6 or 7, diarrhea.
Measured: 2-week run-in period, 2 weeks of treatment, 4 weeks of treatment
Body Mass Index
Measured: baseline, 2 weeks of treatment, 4 weeks of treatment
Self Reported Adverse Effects at Each Study Visit
Adverse effects are problems reported by each study subject that they experienced during this clinical trial. Examples are headache and nausea. Study subjects were asked at each visit while on study drug to report any adverse affects that had occurred since the last visit.
Measured: During entire study period
Serum Sodium
Measured: baseline, 4 weeks
Serum Chloride
Measured: baseline and 4 weeks
Serum Potassium
Measured: baseline and 4 weeks
Serum Bicarb
Measured: baseline and 4 weeks
Serum BUN
Measured: baseline and 4 weeks
Serum Creatinine
Measured: baseline and 4 weeks
AST
Measured: baseline and 4 weeks
ALT
Measured: baseline and 4 weeks
Serum Calcium
Measured: baseline and 4 weeks
Serum Magnesium
Measured: baseline and 4 weeks
Serum Phosphate
Measured: baseline and 4 weeks
Serum Glucose
Measured: baseline and 4 weeks
Serum Vitamin D
Measured: baseline and 4 weeks
Serum Vitamin A
Measured: baseline and 4 weeks
Serum Vitamin E
Measured: baseline and 4 weeks
Serum Prealbumin
Measured: baseline and 4 weeks
Serum Albumin
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ConstipationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Investigators
- Catherine E. O'Brien, Pharm.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706004
- Sponsor's protocol ID
- 76992
- Status last verified
- Mar 2011
- First submitted
- 25 Jun 2008
- Last updated
- 18 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00706004
- Acronym / sponsor ID
- 76992
- Conditions
- Constipation, Cystic Fibrosis
- Keywords
- constipation, cystic fibrosis, lubiprostone, Constipation in adults with cystic fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Posted 18 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cystic fibrosis (CF) affects about 30,000 people in the United States. It is caused by an absent or dysfunctional protein called CF transmembrane conductance regulator (CFTR) which functions as a chloride channel. Lubiprostone is a medication indicated for constipation that activates type 2 chloride channels (ClC-2) and has the potential to be an effective treatment for constipation in adults with CF. It has the potential to correct the underlying disorder by utilizing a chloride channel whose activity does not depend on CFTR. This project is a prospective open-label pilot study to examine the safety and effectiveness of lubiprostone when used in adults with CF with constipation. The specific aims are as follows: 1) Determine the effectiveness of lubiprostone for constipation in participants with CF, and 2) Determine the short term safety of lubiprostone in adults with CF. Data will also be collected to generate further information about the effect of lubiprostone on nutritional status.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| lubiprostoneAlso: Brand name: Amitizalubiprostone 24 microgram capsule taken twice daily for 4 weeks | Drug | – |
Primary outcome
Number of Spontaneous Bowel Movements Per Week
Time frame: 2-week run-in period, 2-weeks of treatment, 4-weeks of treatment
21 secondary outcomes
Patient Assessment of Constipation Symptoms
Time frame: 2-week run-in period, 2 weeks of treatment, 4 weeks of treatment
Bristol Stool Scale Score
Time frame: 2-week run-in period, 2 weeks of treatment, 4 weeks of treatment
Body Mass Index
Time frame: baseline, 2 weeks of treatment, 4 weeks of treatment
Self Reported Adverse Effects at Each Study Visit
Time frame: During entire study period
Serum Sodium
Time frame: baseline, 4 weeks
Serum Chloride
Time frame: baseline and 4 weeks
Serum Potassium
Time frame: baseline and 4 weeks
Serum Bicarb
Time frame: baseline and 4 weeks
Serum BUN
Time frame: baseline and 4 weeks
Serum Creatinine
Time frame: baseline and 4 weeks
AST
Time frame: baseline and 4 weeks
ALT
Time frame: baseline and 4 weeks
Serum Calcium
Time frame: baseline and 4 weeks
Serum Magnesium
Time frame: baseline and 4 weeks
Serum Phosphate
Time frame: baseline and 4 weeks
Serum Glucose
Time frame: baseline and 4 weeks
Serum Vitamin D
Time frame: baseline and 4 weeks
Serum Vitamin A
Time frame: baseline and 4 weeks
Serum Vitamin E
Time frame: baseline and 4 weeks
Serum Prealbumin
Time frame: baseline and 4 weeks
Serum Albumin
Time frame: baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
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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.
Catherine E. O'Brien, Pharm.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lubiprostone in people with Constipation and Cystic Fibrosis, run by University of Arkansas at 1 site in United States.
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 4 inclusion and 10 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 18 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Number of Spontaneous Bowel Movements Per Week (time frame: 2-week run-in period, 2-weeks of treatment, 4-weeks of treatment). It is what the study was designed to measure, not a finding.
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 18 Apr 2011.