Chronic Idiopathic Constipation
Conditions
Keywords
constipation, bowel habits
Brief summary
In this prospective, randomized, double blind study, the aim is to determine the efficacy of Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation (CIC). Patients with CIC, (age 18 - 70) will be enrolled in the study and randomized to Senna or Linaclotide. Patients will be asked to complete questionnaires during the study and will be followed for 12 weeks. Main outcomes include number of daily bowel movements and measures from surveys regarding bowel habits, relief, and satisfaction.
Detailed description
In this prospective, randomized, double blind study, the aim is to determine the efficacy of Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation (CIC). Our hypothesis is that Senna is not inferior to Linaclotide in the treatment of CIC. Seventy patients aged 18-70 diagnosed with CIC and seen by a gastroenterologist affiliated with TriHealth or a patient of the Faculty Medical Center clinic will be included in the study. After enrollment, subjects will be randomized to receive either Linaclotide or Senna over a 12-week period after a 1 week wash-out period. During th study period, subjects will complete a log to record the number of daily bowel movements. The subjects will also complete 3 validated surveys on a weekly basis: Subject's Global Assessment SGA of Relief, Subject's Global Assessment SGA of Bowel Habit, and SGA of Satisfaction with their Bowel Habit. A research nurse will meet with subjects at the beginning of the study and then at 3 monthly visits to administer the study medication and distribute the surveys. The main outcomes measures are change in # of bowel movements and SGA survey scores.
Interventions
DRUGSenna
1 capsule (50 mg) Senna daily for 12 weeks
DRUGLinzess
1 capsule (145 mcg) of Linzess once daily for 12 weeks
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Males and females 18 - 70 years of age. Diagnosed with CIC according to Rome III criteria. Coherent and mentally competent patient to understand and consent for the trial Unremarkable colonoscopy done in past 5 years
Exclusion criteria
Significant diarrhea (defined as loose or watery stool and or more than three bowel movements daily associated with urgency more than 25% of the days in preceding 3 months) Untreated hypothyroidism Organic or structural disease as the cause of patient's symptoms (stricture or tumor) Diseases that affect bowel transit time (Gastroparesis, short bowel syndrome) Evidence of cathartic colon History of alcohol, laxative abuse or illicit drug use Pregnant or lactating women Planning pregnancy or become pregnant during study period Concomitant use of any medication that could alter gastrointestinal motility (Calcium channel blockers, Narcotics, anticholinergics, calcium and aluminium containing antacids, phenothiazines, ferrous sulfate)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Bowel Movements Per Week | 12 weeks | Change from before to after in number of weekly bowel movements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Relief | 12 weeks | Change from before to after treatment in patient assessment of relief - The Subject's Global Assessment (SGA) of Relief was used to measure this outcome. In evaluating subject's response to SGA of relief, subject's who respond with either completely relieved or considerably relieved for at least 50% of the weeks at the end point or somewhat relieved for 100 % of the weeks at the end point will be considered responders to therapy. |
| Change in Assessment of Bowel Habit | 12 weeks | Change from before treatment to after treatment in assessment of bowel habit The Subject's Global Assessment (SGA) of Bowel Habit was used to measure this outcome. Patients were asked how bothersome their constipation was in the past week on a scare from 0 (Absent) to 100 (Very Severe). |
| Change in Satisfaction With Bowel Habit | 12 weeks | Change from before treatment to after treatment on patient satisfaction with bowel habit The Subject's Global Assessment (SGA) of Satisfaction with Bowel Habit was used to measure this outcome. Patients were asked how satisfied they have been with their bowel habits in the previous week on a scale of 0 (Unsatisfied) to 100 (Very Satisfied). |
Countries
United States
Participant flow
Recruitment details
Patients enrolled from November 2014 to June 2015. A total of 16 patients were screened and 9 patients were enrolled. 3 patients did not show up to appointments and did not complete the study; 6 patients completed the study.
Pre-assignment details
1 week wash-out period after enrollment
Participants by arm
| Arm | Count |
|---|---|
| Senna 1 capsule (50 mg) Senna daily for 12 weeks
Senna: 1 capsule (50 mg) Senna daily for 12 weeks | 3 |
| Linzess 1 capsule (145 mcg) once daily for 12 weeks
Linzess: 1 capsule (145 mcg) of Linzess once daily for 12 weeks | 3 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Linzess | Senna | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 10.1 | 50 years STANDARD_DEVIATION 14 | 54 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment United States | 3 participants | 3 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
Change in Number of Bowel Movements Per Week
Change from before to after in number of weekly bowel movements
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senna | Change in Number of Bowel Movements Per Week | 5 weekly bowel movements | Standard Deviation 0.7 |
| Lizness | Change in Number of Bowel Movements Per Week | 2 weekly bowel movements | Standard Deviation 2.6 |
Secondary
Change in Assessment of Bowel Habit
Change from before treatment to after treatment in assessment of bowel habit The Subject's Global Assessment (SGA) of Bowel Habit was used to measure this outcome. Patients were asked how bothersome their constipation was in the past week on a scare from 0 (Absent) to 100 (Very Severe).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senna | Change in Assessment of Bowel Habit | -.20 scores on a scale | Standard Deviation 0.2 |
| Lizness | Change in Assessment of Bowel Habit | -.08 scores on a scale | Standard Deviation 0.1 |
Secondary
Change in Satisfaction With Bowel Habit
Change from before treatment to after treatment on patient satisfaction with bowel habit The Subject's Global Assessment (SGA) of Satisfaction with Bowel Habit was used to measure this outcome. Patients were asked how satisfied they have been with their bowel habits in the previous week on a scale of 0 (Unsatisfied) to 100 (Very Satisfied).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senna | Change in Satisfaction With Bowel Habit | .23 scores on a scale | Standard Deviation 0.32 |
| Lizness | Change in Satisfaction With Bowel Habit | .03 scores on a scale | Standard Deviation 0.21 |
Secondary
Number of Participants With Relief
Change from before to after treatment in patient assessment of relief - The Subject's Global Assessment (SGA) of Relief was used to measure this outcome. In evaluating subject's response to SGA of relief, subject's who respond with either completely relieved or considerably relieved for at least 50% of the weeks at the end point or somewhat relieved for 100 % of the weeks at the end point will be considered responders to therapy.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Senna | Number of Participants With Relief | 2 Participants |
| Lizness | Number of Participants With Relief | 2 Participants |