Chronic Idiopathic Constipation
Conditions
Keywords
constipation, chronic idiopathic constipation, no prior history of surgery to the colon, not on any type of medication that could alter gastrointestinal motility or transit
Brief summary
This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.
Interventions
DRUGlubiprostone
24 micrograms twice daily for 1 week
Sponsors
Takeda Pharmaceuticals North America, Inc.
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chronic idiopathic constipation
Exclusion criteria
* medications that slow gastrointestinal (GI) motility * prior surgery to the GI tract
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric Emptying | Day 1 and Day 7 | gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal) |
Countries
United States
Participant flow
Recruitment details
19 patients entered the study; no dropouts. All patients completed the study; the entire study was contacted at Dartmouth.
Pre-assignment details
No patients were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Lubirprostone | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Lubirprostone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 42 years STANDARD_DEVIATION 12.5 |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 2 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Gastric Emptying
gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)
Time frame: Day 1 and Day 7
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Prior to Treatement With Lubiprostone | Gastric Emptying | 2 Hours after meal | 0.27 percent meal retention |
| Prior to Treatement With Lubiprostone | Gastric Emptying | 4 Hours after meal | 0.04 percent meal retention |
| Post Treatment With Lubiprostone | Gastric Emptying | 2 Hours after meal | 0.384 percent meal retention |
| Post Treatment With Lubiprostone | Gastric Emptying | 4 Hours after meal | 0.051 percent meal retention |
Comparison: Comparison of meal retention between pre-treatment and post treatment at 2 hours post mealp-value: 0.003t-test, 2 sided
Comparison: Comparison of meal retention between pre-treatment and post treatment at 4 hours post mealp-value: 0.122t-test, 2 sided