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CompletedNCT00706004Updated Apr 18, 2011Results posted

Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis

An interventional study of lubiprostone in Constipation and Cystic Fibrosis, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-18.

Sponsored by University of Arkansas · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Constipation
  • Cystic Fibrosis

Keywords

  • constipation
  • cystic fibrosis
  • lubiprostone
  • Constipation in adults with cystic fibrosis
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 9 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Interventions

  • Druglubiprostone

    lubiprostone 24 microgram capsule taken twice daily for 4 weeks

    Also known as: Brand name: Amitiza

06

What researchers measure

Primary outcomes

  1. Number of Spontaneous Bowel Movements Per Week

    Time frame: 2-week run-in period, 2-weeks of treatment, 4-weeks of treatment

Secondary outcomes

  1. 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).

    Time frame: 2-week run-in period, 2 weeks of treatment, 4 weeks of treatment

  2. 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.

    Time frame: 2-week run-in period, 2 weeks of treatment, 4 weeks of treatment

  3. Body Mass Index

    Time frame: baseline, 2 weeks of treatment, 4 weeks of treatment

  4. 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.

    Time frame: During entire study period

  5. Serum Sodium

    Time frame: baseline, 4 weeks

  6. Serum Chloride

    Time frame: baseline and 4 weeks

  7. Serum Potassium

    Time frame: baseline and 4 weeks

  8. Serum Bicarb

    Time frame: baseline and 4 weeks

  9. Serum BUN

    Time frame: baseline and 4 weeks

  10. Serum Creatinine

    Time frame: baseline and 4 weeks

  11. AST

    Time frame: baseline and 4 weeks

  12. ALT

    Time frame: baseline and 4 weeks

  13. Serum Calcium

    Time frame: baseline and 4 weeks

  14. Serum Magnesium

    Time frame: baseline and 4 weeks

  15. Serum Phosphate

    Time frame: baseline and 4 weeks

  16. Serum Glucose

    Time frame: baseline and 4 weeks

  17. Serum Vitamin D

    Time frame: baseline and 4 weeks

  18. Serum Vitamin A

    Time frame: baseline and 4 weeks

  19. Serum Vitamin E

    Time frame: baseline and 4 weeks

  20. Serum Prealbumin

    Time frame: baseline and 4 weeks

  21. Serum Albumin

    Time frame: baseline and 4 weeks

07

Results

Posted Apr 18, 2011

Participant flow

Participant flow — Overall Study
MilestoneLubiprostone
Started9
Completed7
Not completed2
Withdrew: Did not meet eligibility criteria2

Outcome measures

PrimaryNumber of Spontaneous Bowel Movements Per Week
Time frame:
2-week run-in period, 2-weeks of treatment, 4-weeks of treatment
Reported as:
Mean · bowel movements
Number of Spontaneous Bowel Movements Per Week
bowel movementsLubiprostone 24 Mcg Twice Daily
Baseline period9.7 ± 5.7
2 weeks10.8 ± 5.1
4 weeks8.8 ± 2.9
SecondaryPatient 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).

Time frame:
2-week run-in period, 2 weeks of treatment, 4 weeks of treatment
Reported as:
Mean · scores on a scale
Patient Assessment of Constipation Symptoms
scores on a scaleLubiprostone 24 Mcg Twice Daily
Baseline1.18 ± 0.56
2 weeks0.54 ± 0.27
4 weeks0.44 ± 0.36
SecondaryBristol 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.

Time frame:
2-week run-in period, 2 weeks of treatment, 4 weeks of treatment
Reported as:
Mean · scores on a scale
Bristol Stool Scale Score
scores on a scaleLubiprostone 24 Mcg Twice Daily
Baseline3.4 ± 1.1
2 weeks3.6 ± 0.8
4 weeks3.3 ± 1.1
SecondaryBody Mass Index
Time frame:
baseline, 2 weeks of treatment, 4 weeks of treatment
Reported as:
Mean · kg/m^2
Body Mass Index
kg/m^2Lubiprostone 24 Mcg Twice Daily
Baseline24.0 ± 2.8
2 weeks24.0 ± 2.5
4 weeks24.3 ± 2.5
SecondarySelf 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.

Time frame:
During entire study period
Reported as:
Number · participants
Self Reported Adverse Effects at Each Study Visit
participantsLubiprostone 24 Mcg Twice Daily
2 weeks5
4 weeks3
SecondarySerum Sodium
Time frame:
baseline, 4 weeks
Reported as:
Mean · nmol/L
Serum Sodium
nmol/LLubiprostone 24 Mcg Twice Daily
Baseline137.4 ± 2.8
4 weeks139.2 ± 3.6
SecondarySerum Chloride
Time frame:
baseline and 4 weeks
Reported as:
Mean · nmol/L
Serum Chloride
nmol/LLubiprostone 24 Mcg Twice Daily
Baseline103.0 ± 3.9
4 weeks104.3 ± 3.4
SecondarySerum Potassium
Time frame:
baseline and 4 weeks
Reported as:
Mean · nmol/L
Serum Potassium
nmol/LLubiprostone 24 Mcg Twice Daily
Baseline4.4 ± 0.4
4 weeks4.4 ± 0.2
SecondarySerum Bicarb
Time frame:
baseline and 4 weeks
Reported as:
Mean · nmol/L
Serum Bicarb
nmol/LLubiprostone 24 Mcg Twice Daily
Baseline23.8 ± 4.0
4 weeks25.2 ± 3.3
SecondarySerum BUN
Time frame:
baseline and 4 weeks
Reported as:
Mean · mg/dL
Serum BUN
mg/dLLubiprostone 24 Mcg Twice Daily
Baseline13.0 ± 4.6
4 weeks12.7 ± 3.3
SecondarySerum Creatinine
Time frame:
baseline and 4 weeks
Reported as:
Mean · mg/dL
Serum Creatinine
mg/dLLubiprostone 24 Mcg Twice Daily
Baseline0.79 ± 0.15
4 weeks0.84 ± 0.10
SecondaryAST
Time frame:
baseline and 4 weeks
Reported as:
Mean · U/L
AST
U/LLubiprostone 24 Mcg Twice Daily
Baseline20.6 ± 11.1
4 weeks17.5 ± 3.9
SecondaryALT
Time frame:
baseline and 4 weeks
Reported as:
Mean · U/L
ALT
U/LLubiprostone 24 Mcg Twice Daily
Baseline25.1 ± 16.7
4 weeks23.8 ± 14.5
SecondarySerum Calcium
Time frame:
baseline and 4 weeks
Reported as:
Mean · mg/dL
Serum Calcium
mg/dLLubiprostone 24 Mcg Twice Daily
Baseline9.3 ± 0.3
4 weeks9.3 ± 0.2
SecondarySerum Magnesium
Time frame:
baseline and 4 weeks
Reported as:
Mean · mg/dL
Serum Magnesium
mg/dLLubiprostone 24 Mcg Twice Daily
Baseline2.0 ± 0.3
4 weeks2.0 ± 0.2
SecondarySerum Phosphate
Time frame:
baseline and 4 weeks
Reported as:
Mean · mg/dL
Serum Phosphate
mg/dLLubiprostone 24 Mcg Twice Daily
Baseline3.8 ± 0.6
4 weeks3.7 ± 0.5
SecondarySerum Glucose
Time frame:
baseline and 4 weeks
Reported as:
Mean · mg/dL
Serum Glucose
mg/dLLubiprostone 24 Mcg Twice Daily
Baseline150.3 ± 101.9
4 weeks131.8 ± 83.3
SecondarySerum Vitamin D
Time frame:
baseline and 4 weeks
Reported as:
Mean · ng/mL
Serum Vitamin D
ng/mLLubiprostone 24 Mcg Twice Daily
Baseline25.3 ± 15.9
4 weeks25.3 ± 18.4
SecondarySerum Vitamin A
Time frame:
baseline and 4 weeks
Reported as:
Mean · ug/dL
Serum Vitamin A
ug/dLLubiprostone 24 Mcg Twice Daily
Baseline41.3 ± 14.6
4 weeks42.7 ± 23.3
SecondarySerum Vitamin E
Time frame:
baseline and 4 weeks
Reported as:
Mean · mg/L
Serum Vitamin E
mg/LLubiprostone 24 Mcg Twice Daily
Baseline6.6 ± 3.4
4 weeks7.7 ± 6.1
SecondarySerum Prealbumin
Time frame:
baseline and 4 weeks
Reported as:
Mean · mg/dL
Serum Prealbumin
mg/dLLubiprostone 24 Mcg Twice Daily
Baseline22.6 ± 3.3
4 weeks21.5 ± 6.1
SecondarySerum Albumin
Time frame:
baseline and 4 weeks
Reported as:
Mean · g/dL
Serum Albumin
g/dLLubiprostone 24 Mcg Twice Daily
Baseline4.3 ± 0.3
4 weeks4.3 ± 0.2

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lubiprostone—0/7 (0%)6/7 (85.7%)
Most frequent other events
Most frequent other events
EventLubiprostone
NauseaGastrointestinal disorders2/7
Abdominal bloatingGastrointestinal disorders1/7
Abdominal crampingGastrointestinal disorders1/7
HeartburnGastrointestinal disorders1/7
HeadacheGeneral disorders1/7
MigraineGeneral disorders1/7
InsomniaGeneral disorders1/7
DizzinessNervous system disorders1/7
CoughRespiratory, thoracic and mediastinal disorders1/7
Transient chest tightnessRespiratory, thoracic and mediastinal disorders1/7

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Lubiprostone
<=18 years0
Between 18 and 65 years7
>=65 years0
Age Continuous
Age Continuous(years)Lubiprostone
Mean26 ± 5.4
Sex: Female, Male
Sex: Female, Male(Participants)Lubiprostone
Female4
Male3
Region of Enrollment
Region of Enrollment(participants)Lubiprostone
United States7
08

Study locations

1 site
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00706004
Lead sponsor
University of Arkansas
Collaborators
Takeda Pharmaceuticals North America, Inc.
First posted
Jun 27, 2008
Start date
Jul 2008
Primary completion
Dec 2009
Completion
Dec 2009
Results posted
Apr 18, 2011
Last update
Apr 18, 2011

Study contacts

Catherine E. O'Brien, Pharm.D.
principal investigator · University of Arkansas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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