Trial Outcomes & Findings for Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation (NCT NCT00645801)
NCT ID: NCT00645801
Last Updated: 2023-06-01
Results Overview
Endoscopists evaluated the quality of the colonoscopy preparation based on Ottawa bowel preparation scale. . The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. Before using the scale for this trial, the endoscopists participated in a calibration exercise that involved 20 patients to ensure that they concurred on their interpretation of the scale.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
158 participants
Primary outcome timeframe
within 12 hours of completing bowel prep
Results posted on
2023-06-01
Participant Flow
Two hundred patients were planned to enroll in the study; however, the study was discontinued by the sponsor before the enrollment goal was completed because of slow enrollment. Of the 157 patients who volunteered for the study, only 123 patients who actually did the bowel preparation. Patients were recruited from the gastroenterology clinic at the main hospital and at the satellite clinic in the suburbs of Detroit.
Exclusion criteria included serum creatinine greater than 1.4, type I diabetes, CHF, pre-existing electrolyte abnormalities, inflammatory bowel disease, no spontaneous bowel movement every 48 hours, more than 3 bowel movements daily and previous colon resection.
Participant milestones
| Measure |
1 Patient Received Both Lubiprostone in 4 Divided Doses and Golytely.
First dose of lubiprostone was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continued drinking the solution until at least 2 bowel movements were clear yellow or green. After completing the preparation but before colonoscopy, patients were also required to fill a questionnaire to assess the tolerability of tablets and solution. This was measured on a 1-5 rating Likert scale 1) Easy, up to 5) Unable to Finish. In addition, the presence of symptoms of nausea, vomiting, abdominal pain, chest pain, dizziness, and bloating was also noted. All colonoscopies were performed by 3 endoscopists (with 85% of the procedures performed by principal investigator of the study, A.L.S.). Endoscopists evaluated the quality of the colonoscopy preparation based on the Ottawa bowel preparation scale. This scale rates 3 sections of colon, rectosigmoid, mid, and right colon, on a 5-point scale (0-4) and a global 3-point rating (0-2) for overall colonic fluid. The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. All patients were contacted by telephone the day after the procedure to determine if they were experiencing any adverse reactions.
|
2 Look Alike Placebo in 4 Divided Doses Plus PEG and Electrolytes.
group 2 ingested 4 tablets of placebo (in divided doses) + 1 gallon of PEG. First dose of placebo was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continue drinking the solution until at least 2 bowel movements were clear yellow or green. Patients evaluated the prep on a 1-5 rating Likert scale 1)Easy, to 5) Unable to Finish In addition, the presence of symptoms of nausea, vomiting, abdominal pain, chest pain, dizziness, and bloating were also recorded.All colonoscopies were performed by 3 endoscopists (with 85% of the procedures performed by principal investigator of the study, A.L.S.). Endoscopists evaluated the quality of the colonoscopy preparation based on the Ottawa bowel preparation scale. This scale rates 3 sections of colon, rectosigmoid, mid, and right colon, on a 5-point scale (0-4) and a global 3-point rating (0-2) for overall colonic fluid. The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. All patients were contacted by telephone the day after the procedure to determine if they were experiencing any adverse reactions.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
81
|
|
Overall Study
COMPLETED
|
57
|
66
|
|
Overall Study
NOT COMPLETED
|
20
|
15
|
Reasons for withdrawal
| Measure |
1 Patient Received Both Lubiprostone in 4 Divided Doses and Golytely.
First dose of lubiprostone was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continued drinking the solution until at least 2 bowel movements were clear yellow or green. After completing the preparation but before colonoscopy, patients were also required to fill a questionnaire to assess the tolerability of tablets and solution. This was measured on a 1-5 rating Likert scale 1) Easy, up to 5) Unable to Finish. In addition, the presence of symptoms of nausea, vomiting, abdominal pain, chest pain, dizziness, and bloating was also noted. All colonoscopies were performed by 3 endoscopists (with 85% of the procedures performed by principal investigator of the study, A.L.S.). Endoscopists evaluated the quality of the colonoscopy preparation based on the Ottawa bowel preparation scale. This scale rates 3 sections of colon, rectosigmoid, mid, and right colon, on a 5-point scale (0-4) and a global 3-point rating (0-2) for overall colonic fluid. The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. All patients were contacted by telephone the day after the procedure to determine if they were experiencing any adverse reactions.
|
2 Look Alike Placebo in 4 Divided Doses Plus PEG and Electrolytes.
group 2 ingested 4 tablets of placebo (in divided doses) + 1 gallon of PEG. First dose of placebo was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continue drinking the solution until at least 2 bowel movements were clear yellow or green. Patients evaluated the prep on a 1-5 rating Likert scale 1)Easy, to 5) Unable to Finish In addition, the presence of symptoms of nausea, vomiting, abdominal pain, chest pain, dizziness, and bloating were also recorded.All colonoscopies were performed by 3 endoscopists (with 85% of the procedures performed by principal investigator of the study, A.L.S.). Endoscopists evaluated the quality of the colonoscopy preparation based on the Ottawa bowel preparation scale. This scale rates 3 sections of colon, rectosigmoid, mid, and right colon, on a 5-point scale (0-4) and a global 3-point rating (0-2) for overall colonic fluid. The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. All patients were contacted by telephone the day after the procedure to determine if they were experiencing any adverse reactions.
|
|---|---|---|
|
Overall Study
unclear if patient took all the medication.
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
19
|
15
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
2 Look Alike Placebo in 4 Divided Doses Plus PEG and Electrolytes.
n=66 Participants
group 2 ingested 4 tablets of placebo (in divided doses) + 1 gallon of PEG. First dose of placebo was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continue drinking the solution until at least 2 bowel movements were clear yellow or green. Patients evaluated the prep on a 1-5 rating Likert scale 1)Easy, to 5) Unable to Finish In addition, the presence of symptoms of nausea, vomiting, abdominal pain, chest pain, dizziness, and bloating were also recorded.All colonoscopies were performed by 3 endoscopists (with 85% of the procedures performed by principal investigator of the study, A.L.S.). Endoscopists evaluated the quality of the colonoscopy preparation based on the Ottawa bowel preparation scale. This scale rates 3 sections of colon, rectosigmoid, mid, and right colon, on a 5-point scale (0-4) and a global 3-point rating (0-2) for overall colonic fluid. The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. All patients were contacted by telephone the day after the procedure to determine if they were experiencing any adverse reactions.
|
1 Patient Received Both Lubiprostone in 4 Divided Doses and Golytely.
n=57 Participants
First dose of lubiprostone was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continued drinking the solution until at least 2 bowel movements were clear yellow or green. After completing the preparation but before colonoscopy, patients were also required to fill a questionnaire to assess the tolerability of tablets and solution. This was measured on a 1-5 rating Likert scale 1) Easy, up to 5) Unable to Finish. In addition, the presence of symptoms of nausea, vomiting, abdominal pain, chest pain, dizziness, and bloating was also noted. All colonoscopies were performed by 3 endoscopists (with 85% of the procedures performed by principal investigator of the study, A.L.S.). Endoscopists evaluated the quality of the colonoscopy preparation based on the Ottawa bowel preparation scale. This scale rates 3 sections of colon, rectosigmoid, mid, and right colon, on a 5-point scale (0-4) and a global 3-point rating (0-2) for overall colonic fluid. The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. All patients were contacted by telephone the day after the procedure to determine if they were experiencing any adverse reactions.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
age
|
56.1 years
STANDARD_DEVIATION 9.1 • n=66 Participants
|
55.8 years
STANDARD_DEVIATION 9.4 • n=57 Participants
|
56.0 years
STANDARD_DEVIATION 9.2 • n=123 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=66 Participants
|
35 Participants
n=57 Participants
|
76 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=66 Participants
|
22 Participants
n=57 Participants
|
47 Participants
n=123 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
66 participants
n=66 Participants
|
57 participants
n=57 Participants
|
123 participants
n=123 Participants
|
PRIMARY outcome
Timeframe: within 12 hours of completing bowel prepEndoscopists evaluated the quality of the colonoscopy preparation based on Ottawa bowel preparation scale. . The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. Before using the scale for this trial, the endoscopists participated in a calibration exercise that involved 20 patients to ensure that they concurred on their interpretation of the scale.
Outcome measures
| Measure |
Look Alike Placebo in 4 Divided Doses Plus PEG and Electrolytes.
n=66 Participants
group 2 ingested 4 tablets of placebo (in divided doses) + 1 gallon of PEG. First dose of placebo was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continue drinking the solution until at least 2 bowel movements were clear yellow or green. Patients evaluated the prep on a 1-5 rating Likert scale 1)Easy, to 5) Unable to Finish In addition, the presence of symptoms of nausea, vomiting, abdominal pain, chest pain, dizziness, and bloating were also recorded.All colonoscopies were performed by 3 endoscopists (with 85% of the procedures performed by principal investigator of the study, A.L.S.). Endoscopists evaluated the quality of the colonoscopy preparation based on the Ottawa bowel preparation scale. This scale rates 3 sections of colon, rectosigmoid, mid, and right colon, on a 5-point scale (0-4) and a global 3-point rating (0-2) for overall colonic fluid. The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. All patients were contacted by telephone the day after the procedure to determine if they were experiencing any adverse reactions.
|
Patient Received Both Lubiprostone in 4 Divided Doses and Golytely.
n=57 Participants
First dose of lubiprostone was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continued drinking the solution until at least 2 bowel movements were clear yellow or green. After completing the preparation but before colonoscopy, patients were also required to fill a questionnaire to assess the tolerability of tablets and solution. This was measured on a 1-5 rating Likert scale 1) Easy, up to 5) Unable to Finish. In addition, the presence of symptoms of nausea, vomiting, abdominal pain, chest pain, dizziness, and bloating was also noted. All colonoscopies were performed by 3 endoscopists (with 85% of the procedures performed by principal investigator of the study, A.L.S.). Endoscopists evaluated the quality of the colonoscopy preparation based on the Ottawa bowel preparation scale. This scale rates 3 sections of colon, rectosigmoid, mid, and right colon, on a 5-point scale (0-4) and a global 3-point rating (0-2) for overall colonic fluid. The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. All patients were contacted by telephone the day after the procedure to determine if they were experiencing any adverse reactions.
|
|---|---|---|
|
Endoscopist Evaluation of Colon Cleanliness in the Lubiprostone Group vs the Placebo Group
|
1.38 score on a scale
Standard Deviation 0.49
|
1.24 score on a scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: done at the time of colonoscopyPopulation: Patients completed the drug or placebo with PEG and completed a questionnaire on the day of of the colonoscopy
After completing the colonoscopy prep patients were asked to assess tolerability of the prep using a 5 point Likert scale with 1 being easy and 5 being unable to complete the prep
Outcome measures
| Measure |
Look Alike Placebo in 4 Divided Doses Plus PEG and Electrolytes.
n=52 Participants
group 2 ingested 4 tablets of placebo (in divided doses) + 1 gallon of PEG. First dose of placebo was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continue drinking the solution until at least 2 bowel movements were clear yellow or green. Patients evaluated the prep on a 1-5 rating Likert scale 1)Easy, to 5) Unable to Finish In addition, the presence of symptoms of nausea, vomiting, abdominal pain, chest pain, dizziness, and bloating were also recorded.All colonoscopies were performed by 3 endoscopists (with 85% of the procedures performed by principal investigator of the study, A.L.S.). Endoscopists evaluated the quality of the colonoscopy preparation based on the Ottawa bowel preparation scale. This scale rates 3 sections of colon, rectosigmoid, mid, and right colon, on a 5-point scale (0-4) and a global 3-point rating (0-2) for overall colonic fluid. The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. All patients were contacted by telephone the day after the procedure to determine if they were experiencing any adverse reactions.
|
Patient Received Both Lubiprostone in 4 Divided Doses and Golytely.
n=64 Participants
First dose of lubiprostone was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continued drinking the solution until at least 2 bowel movements were clear yellow or green. After completing the preparation but before colonoscopy, patients were also required to fill a questionnaire to assess the tolerability of tablets and solution. This was measured on a 1-5 rating Likert scale 1) Easy, up to 5) Unable to Finish. In addition, the presence of symptoms of nausea, vomiting, abdominal pain, chest pain, dizziness, and bloating was also noted. All colonoscopies were performed by 3 endoscopists (with 85% of the procedures performed by principal investigator of the study, A.L.S.). Endoscopists evaluated the quality of the colonoscopy preparation based on the Ottawa bowel preparation scale. This scale rates 3 sections of colon, rectosigmoid, mid, and right colon, on a 5-point scale (0-4) and a global 3-point rating (0-2) for overall colonic fluid. The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. All patients were contacted by telephone the day after the procedure to determine if they were experiencing any adverse reactions.
|
|---|---|---|
|
Tolerability of the Colon Cleansing Group in the Lubiprostone Group vs the Placebo Group
easy
|
6 participants
|
4 participants
|
|
Tolerability of the Colon Cleansing Group in the Lubiprostone Group vs the Placebo Group
Tolerable
|
15 participants
|
14 participants
|
|
Tolerability of the Colon Cleansing Group in the Lubiprostone Group vs the Placebo Group
slightly difficult
|
18 participants
|
25 participants
|
|
Tolerability of the Colon Cleansing Group in the Lubiprostone Group vs the Placebo Group
extremely difficult
|
6 participants
|
15 participants
|
|
Tolerability of the Colon Cleansing Group in the Lubiprostone Group vs the Placebo Group
unable to finish
|
7 participants
|
6 participants
|
SECONDARY outcome
Timeframe: amount of PEG at start of the study and that measured when the patient presented for their procedure.Patients in the lubiprostone group and the placebo returned unused PEG after completing the prep for the colonoscopy. This was measured in liters and recorded.
Outcome measures
| Measure |
Look Alike Placebo in 4 Divided Doses Plus PEG and Electrolytes.
n=57 Participants
group 2 ingested 4 tablets of placebo (in divided doses) + 1 gallon of PEG. First dose of placebo was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continue drinking the solution until at least 2 bowel movements were clear yellow or green. Patients evaluated the prep on a 1-5 rating Likert scale 1)Easy, to 5) Unable to Finish In addition, the presence of symptoms of nausea, vomiting, abdominal pain, chest pain, dizziness, and bloating were also recorded.All colonoscopies were performed by 3 endoscopists (with 85% of the procedures performed by principal investigator of the study, A.L.S.). Endoscopists evaluated the quality of the colonoscopy preparation based on the Ottawa bowel preparation scale. This scale rates 3 sections of colon, rectosigmoid, mid, and right colon, on a 5-point scale (0-4) and a global 3-point rating (0-2) for overall colonic fluid. The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. All patients were contacted by telephone the day after the procedure to determine if they were experiencing any adverse reactions.
|
Patient Received Both Lubiprostone in 4 Divided Doses and Golytely.
n=66 Participants
First dose of lubiprostone was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continued drinking the solution until at least 2 bowel movements were clear yellow or green. After completing the preparation but before colonoscopy, patients were also required to fill a questionnaire to assess the tolerability of tablets and solution. This was measured on a 1-5 rating Likert scale 1) Easy, up to 5) Unable to Finish. In addition, the presence of symptoms of nausea, vomiting, abdominal pain, chest pain, dizziness, and bloating was also noted. All colonoscopies were performed by 3 endoscopists (with 85% of the procedures performed by principal investigator of the study, A.L.S.). Endoscopists evaluated the quality of the colonoscopy preparation based on the Ottawa bowel preparation scale. This scale rates 3 sections of colon, rectosigmoid, mid, and right colon, on a 5-point scale (0-4) and a global 3-point rating (0-2) for overall colonic fluid. The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. All patients were contacted by telephone the day after the procedure to determine if they were experiencing any adverse reactions.
|
|---|---|---|
|
Change in Volume of PEG From Beginning of Bowel Prep to That at Completion of the Colonoscopy Preparation in the Two Groups
|
0.79 liters
Standard Deviation 0.97
|
1.36 liters
Standard Deviation 1.04
|
Adverse Events
Ingested 4 Tablets of Lubiprostone in Divided Doses + 1 Gallon of Polyethylene Glycol
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Ingested 4 Tablets of Placebo in Divided Doses + 1 Gallon of Polyethylene Glycol
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ingested 4 Tablets of Lubiprostone in Divided Doses + 1 Gallon of Polyethylene Glycol
n=57 participants at risk
lubiprostone (Amitiza): 24 mcg administered 4 times over the two days of the colon preparation with PEG plus electrolytes before the colonoscopy. 96 mcg total lubiprostone
|
Ingested 4 Tablets of Placebo in Divided Doses + 1 Gallon of Polyethylene Glycol
n=66 participants at risk
Placebo: Amitiza Placebo 4 times over the two days of the colon preparation in divided doses with PEG plus electrolytes before the colonoscopy.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
36.8%
21/57 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
37.9%
25/66 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
|
Gastrointestinal disorders
bloating
|
15.8%
9/57 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
19.7%
13/66 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
|
Nervous system disorders
headache
|
10.5%
6/57 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
4.5%
3/66 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/57 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
4.5%
3/66 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/57 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
3.0%
2/66 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
|
Nervous system disorders
Tingling of extremities
|
1.8%
1/57 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
1.5%
1/66 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
|
Gastrointestinal disorders
anal irritation
|
1.8%
1/57 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
0.00%
0/66 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
|
Nervous system disorders
Dizziness
|
5.3%
3/57 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
3.0%
2/66 • Adverse events were collected over the 2 days that the patients took lubiprostone or placebo.
Patients were asked to describe any symptoms during colonoscopy prep
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place