Efficacy of Linaclotide to Senna for CIC
Stopped early · Not applicable
Conditions studied: Chronic Idiopathic Constipation
In brief
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.
Key facts
- Study ID
- NCT02239510
- Run by
- TriHealth Inc.
- People needed
- 9
- Starts
- 2014-09-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2019-07-02
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- TriHealth — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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