An interventional study of Senna and Linzess in Chronic Idiopathic Constipation, sponsored by TriHealth Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-02.
Sponsored by TriHealth Inc. · Not applicable, Interventional, and Treatment
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.
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 9 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →TriHealth Inc. is the lead sponsor of 99 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
1 capsule (50 mg) Senna daily for 12 weeks
Drug: Senna
1 capsule (145 mcg) once daily for 12 weeks
Drug: Linzess
1 capsule (50 mg) Senna daily for 12 weeks
Also known as: sennoside
1 capsule (145 mcg) of Linzess once daily for 12 weeks
Also known as: Linaclotide
Change in Number of Bowel Movements Per Week
Change from before to after in number of weekly bowel movements
Time frame: 12 weeks
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
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
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
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.
| Milestone | Senna | Lizness |
|---|---|---|
| Started | 5 | 4 |
| Completed | 3 | 3 |
| Not completed | 2 | 1 |
| Withdrew: Lost to follow-up | 2 | 1 |
Change from before to after in number of weekly bowel movements
| weekly bowel movements | Senna | Lizness |
|---|---|---|
| Change in Number of Bowel Movements Per Week | 5 ± .7 | 2 ± 2.6 |
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.
| Participants | Senna | Lizness |
|---|---|---|
| Number of Participants With Relief | 2 | 2 |
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).
| scores on a scale | Senna | Lizness |
|---|---|---|
| Change in Assessment of Bowel Habit | -.20 ± .20 | -.08 ± .10 |
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).
| scores on a scale | Senna | Lizness |
|---|---|---|
| Change in Satisfaction With Bowel Habit | .23 ± .32 | .03 ± .21 |
Collected over 16 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Senna | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Linzess | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Senna | Linzess | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 2 | 5 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | Senna | Linzess | Total |
|---|---|---|---|
| Mean | 50 ± 14.0 | 58 ± 10.1 | 54 ± 11.9 |
| Sex: Female, Male(Participants) | Senna | Linzess | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Senna | Linzess | Total |
|---|---|---|---|
| United States | 3 | 3 | 6 |
Plan to share: No — Recruitment was low and therefore results are insufficient to share.
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This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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