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Effect of Lubiprostone on Small Bowel Contractions in Female Patients With Constipation Irritable Bowel Syndrome (C-IBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01085643
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : December 12, 2011
Last Update Posted : December 12, 2011
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Edy E Soffer, Cedars-Sinai Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Condition Constipation-predominant Irritable Bowel Syndrome
Interventions Drug: Lubiprostone
Drug: Placebo
Enrollment 4
Recruitment Details Recruitment dates: March 2010 to December 2010 Recruitment place: GI Motility Clinic
Pre-assignment Details 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.
Arm/Group Title Placebo Then Lubiprostone
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Placebo Then Lubiprostone
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  75.0%
>=65 years
1
  25.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
45  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title A Change in Length of Spread of Antegrade Contractions After Placebo.
Hide Description 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.
Time Frame baseline and within the following 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Then Lubiprostone
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title A Change in Length of Spread of Antegrade Contractions After Lubiprostone
Hide Description 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.
Time Frame baseline and within the following 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Then Lubiprostone
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title A Change in Length of Spread of Long Distance Propagating Contractions After Placebo.
Hide Description 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.
Time Frame baseline and within the following 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Then Lubiprostone
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title A Change in Length of Spread of Retrograde Contractions After Placebo
Hide Description 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.
Time Frame baseline and within the following 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Then Lubiprostone
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title A Change in Length of Spread of Long Distance Propagating Contractions After Lubiprostone
Hide Description 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.
Time Frame baseline and within the following 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Then Lubiprostone
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title A Change in Length of Spread of Retrograde Contractions After Lubiprostone
Hide Description 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.
Time Frame baseline and within the following 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Then Lubiprostone
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Then Lubiprostone
Hide Arm/Group Description 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.
All-Cause Mortality
Placebo Then Lubiprostone
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Placebo Then Lubiprostone
Affected / at Risk (%)
Total   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Then Lubiprostone
Affected / at Risk (%)
Total   0/4 (0.00%) 
Limited time period resulting in recruitment of only 4 patients.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Edy Soffer, MD
Organization: Cedars-Sinai Medical Center
Phone: (310) 423-6143
EMail: edy.soffer@cshs.org
Layout table for additonal information
Responsible Party: Edy E Soffer, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01085643    
Other Study ID Numbers: 17482
First Submitted: March 11, 2010
First Posted: March 12, 2010
Results First Submitted: June 22, 2011
Results First Posted: December 12, 2011
Last Update Posted: December 12, 2011