Trial Outcomes & Findings for Lubiprostone and Mucus Secretion in Patients With Chronic Constipation (NCT NCT01447849)
NCT ID: NCT01447849
Last Updated: 2017-06-09
Results Overview
The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).
COMPLETED
PHASE2/PHASE3
40 participants
Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between.
2017-06-09
Participant Flow
During an entire recruitment time all patients signed their consent forms and participate in the study protocol within the specially designated clinical research room at Texas Tech University Health Sciences Center(TTUHSC), El Paso.
Patients interested in our study were interviewed and examined 1 week before the 1st assigned after randomization medication was administered for one week of therapy. Subsequently, when patients finished their first week of medication, they had one week as of wash-out before the 2nd therapy in this cross-over design of our study protocol.
Participant milestones
| Measure |
Chronic Constipation (CC)Subjects on Lubiprostone Then Placebo
Subjects with chronic constipation received 1 week of therapy with lubiprostone,then washed out for 1 week, then received 1 week of therapy with placebo.
lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week
|
Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone
Subjects with chronic constipation received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.
placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week
|
Controls on Lubiprostone Then Placebo
Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week
|
Controls on Placebo Then Lubiprostone
Control group received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.
placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week
|
|---|---|---|---|---|
|
First Intervention
STARTED
|
10
|
10
|
10
|
10
|
|
First Intervention
COMPLETED
|
10
|
10
|
10
|
10
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period for 1 Week
STARTED
|
10
|
10
|
10
|
10
|
|
Washout Period for 1 Week
COMPLETED
|
10
|
10
|
10
|
10
|
|
Washout Period for 1 Week
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
10
|
10
|
10
|
10
|
|
Second Intervention
COMPLETED
|
10
|
10
|
10
|
10
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lubiprostone and Mucus Secretion in Patients With Chronic Constipation
Baseline characteristics by cohort
| Measure |
Chronic Constipation(CC) Subjects on Lubiprostone Then Placebo
n=10 Participants
Subjects with chronic constipation (CC) received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week
|
Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone
n=10 Participants
Subjects with chronic constipation (CC)received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.
placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week
|
Controls on Lubiprostone Then Placebo
n=10 Participants
Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week
|
Controls on Placebo Then Lubiprostone
n=10 Participants
Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 16 • n=5 Participants
|
37 years
STANDARD_DEVIATION 16 • n=7 Participants
|
42 years
STANDARD_DEVIATION 18 • n=5 Participants
|
42 years
STANDARD_DEVIATION 18 • n=4 Participants
|
40 years
STANDARD_DEVIATION 17 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
40 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between.Population: Number of participants was calculated to provide statistical power of 0.80 for detection of significance.
The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).
Outcome measures
| Measure |
Lubiprostone 24 mcg BID
n=40 Participants
Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
|
Placebo
n=40 Participants
Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
|
|---|---|---|
|
Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls.
Mucus Secretion in Chronic Constipation Subjects
|
260 mg/hour
Standard Error 29
|
133 mg/hour
Standard Error 16
|
|
Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls.
Mucus Secretion in Controls
|
229 mg/hour
Standard Error 33
|
161 mg/hour
Standard Error 25
|
|
Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls.
Mucin Secretion in Chronic Constipation Subjects
|
99 mg/hour
Standard Error 14
|
54 mg/hour
Standard Error 7
|
|
Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls.
Mucin Secretion in Controls
|
100 mg/hour
Standard Error 16
|
69 mg/hour
Standard Error 14
|
SECONDARY outcome
Timeframe: Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between.Population: To provide 0.80 statistical power for detection of significance.
The viscoelasticity of gastric mucus(centipoises) was measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).
Outcome measures
| Measure |
Lubiprostone 24 mcg BID
n=40 Participants
Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
|
Placebo
n=40 Participants
Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
|
|---|---|---|
|
Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation.
Basal viscosity in chronic constipation subjects
|
21.61 Centipoises
Standard Error 2.95
|
6.34 Centipoises
Standard Error 1.01
|
|
Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation.
Basal viscosity in controls
|
12.78 Centipoises
Standard Error 2.53
|
9.41 Centipoises
Standard Error 1.74
|
|
Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation.
Pentagastrin-Stimulated viscosity in CC
|
14.96 Centipoises
Standard Error 3.00
|
4.59 Centipoises
Standard Error 1.20
|
|
Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation.
Pentagastrin-Stimulated viscosity in Controls
|
10.58 Centipoises
Standard Error 2.20
|
7.84 Centipoises
Standard Error 1.71
|
Adverse Events
Chronic Constipation Subjects on Lubiprostone Then Placebo
Chronic Constipation Subjects on Placebo Then Lubiprostone
Controls on Lubiprostone Then Placebo
Controls on Placebo Then Lubiprostone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jerzy Sarosiek, Director, Mol. Medicine Research
TexasTech
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place