Chronic Idiopathic Constipation Clinical Trial
Official title:
A Randomized, Double-Blind, Trial Comparing the Efficacy of Linaclotide to Senna in Relieving Symptoms in Patients With Chronic Idiopathic Constipation (CIC)
NCT number | NCT02239510 |
Other study ID # | 14040 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2014 |
Est. completion date | June 2016 |
Verified date | October 2018 |
Source | TriHealth Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | TriHealth | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
TriHealth Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Number of Bowel Movements Per Week | Change from before to after in number of weekly bowel movements | 12 weeks | |
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. | 12 weeks | |
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). | 12 weeks | |
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). | 12 weeks |
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