Trial Outcomes & Findings for Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation (NCT NCT01469819)

NCT ID: NCT01469819

Last Updated: 2017-06-09

Results Overview

The change in transit time (TT), in hours and minutes, of gastric emptying (GE), small bowel (SB), large bowel (LB) and whole gut (WG) measured by SmartPill in 29 patients with chronic constipation after taking lubiprostone 24 micrograms twice a day (BID) for 2 weeks.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 37 participants
• Primary outcome timeframe: Measured at baseline and 2 weeks after baseline.
• Results posted on: 2017-06-09

Participant Flow

Participants recruited from University of Kansas Medical Center, in Kansas City, KS from July 2008 to August 2009. Additional participants were recruited from Texas Tech University Health Sciences Center - El Paso, in El Paso, TX between April 2012 and November 2012.

37 participants recruited; 37 screened, 8 excluded. 25 of those subjects participated in small intestinal bacterial overgrowth (SIBO) testing and analysis.

Participant milestones

Measure	All Participants Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
Overall Study STARTED	37
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	All Participants Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
Overall Study Withdrawal by Subject	1
Overall Study Did not meet inclusionary criteria	2
Overall Study Could not swallow SmartPill	2
Overall Study Technical malfunction of SmartPill data	3

Baseline Characteristics

Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation

Baseline characteristics by cohort

Measure	All Participants n=29 Participants Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline and 2 weeks after baseline.

The change in transit time (TT), in hours and minutes, of gastric emptying (GE), small bowel (SB), large bowel (LB) and whole gut (WG) measured by SmartPill in 29 patients with chronic constipation after taking lubiprostone 24 micrograms twice a day (BID) for 2 weeks.

Outcome measures

Measure	All Participants n=29 Participants Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.	Non-Responders Subgroup of patients who had \<2 times increase in their weekly bowel movement.
Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day. Whole Gut Transit Time after treatment	52.5 Hours Standard Error 4.8	—
Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day. Gastric Emptying Time before treatment	7.0 Hours Standard Error 1.1	—
Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day. Small Bowel Transit Time before treatment	5.9 Hours Standard Error 1.1	—
Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day. Small & Large Bowel Transit Time before treatment	56.7 Hours Standard Error 8.7	—
Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day. Whole Gut Transit Time before treatment	64.2 Hours Standard Error 8.5	—
Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day. Gastric Emptying Time after treatment	9.3 Hours Standard Error 1.9	—
Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day. Small Bowel Transit Time after treatment	4.5 Hours Standard Error 0.4	—
Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day. Small & Large Bowel Transit Time after treatment	43.2 Hours Standard Error 4.6	—

SECONDARY outcome

Timeframe: Measured at baseline and 2 weeks after baseline

Outcome measures

Measure	All Participants n=29 Participants Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.	Non-Responders Subgroup of patients who had \<2 times increase in their weekly bowel movement.
Changes in Number of Bowel Movements in Chronically Constipated Patients After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day (BID). Bowel Movements before treatment	1.9 number per week Standard Error 0.1	—
Changes in Number of Bowel Movements in Chronically Constipated Patients After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day (BID). Bowel Movements after treatment	4.6 number per week Standard Error 0.4	—

SECONDARY outcome

Timeframe: Measured at baseline and 2 weeks after baseline.

Changes in Time of GE, SB, LB and WG transits measured by SmartPill after 2 weeks of lubiprostone 24mcg BID in chronically constipated patients who increased stool frequency to ≥ 2 times increase per week vs. patients who increased stool frequency < 2 times increase per week.

Outcome measures

Measure	All Participants n=16 Participants Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.	Non-Responders n=13 Participants Subgroup of patients who had \<2 times increase in their weekly bowel movement.
Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients. Small Bowel Transit Time after treatment	4.4 Hours Standard Error 0.6	4.5 Hours Standard Error 0.5
Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients. Gastric Emptying Time before treatment	9.6 Hours Standard Error 1.5	3.9 Hours Standard Error 1.2
Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients. Small Bowel Transit Time before treatment	7.2 Hours Standard Error 2.1	4.5 Hours Standard Error 0.3
Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients. Small & Large Bowel Transit Time before treatment	45.9 Hours Standard Error 6.8	70.1 Hours Standard Error 17.3
Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients. Whole Gut Transit Time before treatment	55.5 Hours Standard Error 6.3	75.0 Hours Standard Error 17.3
Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients. Gastric Emptying Time after treatment	11.6 Hours Standard Error 2.9	6.4 Hours Standard Error 2.1
Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients. Small & Large Bowel Transit Time after treatment	32.0 Hours Standard Error 4.3	57.0 Hours Standard Error 7.2
Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients. Whole Gut Transit Time after treatment	43.7 Hours Standard Error 4.6	63.4 Hours Standard Error 8.5

SECONDARY outcome

Timeframe: Measured at baseline and 2 weeks after baseline.

Population: Number of Bowel Movements per week

Outcome measures

Measure	All Participants n=16 Participants Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.	Non-Responders n=13 Participants Subgroup of patients who had \<2 times increase in their weekly bowel movement.
Changes in Number of Bowel Movements Per Week Changes GE, SB, LB and WG Transit Times Measured by SmartPill in Chronically Constipated Patients Treated for 2 Weeks With Lubiprostone 24mcg Twice a Day. Bowel Movements after treatment	6.0 number per week Standard Error 0.5	3.0 number per week Standard Error 0.2
Changes in Number of Bowel Movements Per Week Changes GE, SB, LB and WG Transit Times Measured by SmartPill in Chronically Constipated Patients Treated for 2 Weeks With Lubiprostone 24mcg Twice a Day. Bowel Movements before treatment	1.8 number per week Standard Error 0.1	2.1 number per week Standard Error 0.2

SECONDARY outcome

Timeframe: Measured at baseline and 2 weeks after baseline.

Outcome measures

Measure	All Participants n=17 Participants Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.	Non-Responders Subgroup of patients who had \<2 times increase in their weekly bowel movement.
Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks. SIBO (+) participants before treatment	17 participants	—
Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks. SIBO (+) participants after treatment	10 participants	—
Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks. SIBO (+)→SIBO (-) participants after treatments	7 participants	—

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=29 participants at risk Due to the nature of this project, which did not include placebo, blinded portion to the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
Gastrointestinal disorders Nausea	20.7% 6/29 • Number of events 6

Additional Information

Dr. Irene Sarosiek

Texas Tech University Health Sciences Center El Paso

Phone: (915)215-5254

Email: irene.sarosiek@ttuhsc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place