Trial Outcomes & Findings for Effect of Lubiprostone on Small Bowel Contractions in Female Patients With Constipation Irritable Bowel Syndrome (C-IBS) (NCT NCT01085643)
NCT ID: NCT01085643
Last Updated: 2011-12-12
Results Overview
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is \>10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.
COMPLETED
NA
4 participants
baseline and within the following 3 hours
2011-12-12
Participant Flow
Recruitment dates: March 2010 to December 2010 Recruitment place: GI Motility Clinic
Subjects will have to stop medications affecting small bowel motility 7 days prior to the procedure. Risks expected in this washout period include recurrence of constipation predominant Irritable Bowel Syndrome symptoms- abdominal pain, bloating and constipation. Subjects will be instructed to call the study staff if symptom recurrence occurs.
Participant milestones
| Measure |
Placebo Then Lubiprostone
Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
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|---|---|
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Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Lubiprostone on Small Bowel Contractions in Female Patients With Constipation Irritable Bowel Syndrome (C-IBS)
Baseline characteristics by cohort
| Measure |
Placebo Then Lubiprostone
n=4 Participants
Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
45 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and within the following 3 hoursPopulation: Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is \>10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: baseline and within the following 3 hoursPopulation: Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is \>10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and within the following 3 hoursPopulation: Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is \>10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and within the following 3 hoursPopulation: Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is \>10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and within the following 3 hoursPopulation: Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is \>10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Lubiprostone)and within the following 3 hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and within the following 3 hoursPopulation: Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is \>10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Lubiprostone)and within the following 3 hours.
Outcome measures
Outcome data not reported
Adverse Events
Placebo Then Lubiprostone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60