Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Linaclotide to Senna for CIC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02239510
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Constipation Drug: Senna Drug: Linzess Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Trial Comparing the Efficacy of Linaclotide to Senna in Relieving Symptoms in Patients With Chronic Idiopathic Constipation (CIC)
Study Start Date : September 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Active Comparator: Senna
1 capsule (50 mg) Senna daily for 12 weeks
Drug: Senna
1 capsule (50 mg) Senna daily for 12 weeks
Other Name: sennoside

Active Comparator: Linzess
1 capsule (145 mcg) once daily for 12 weeks
Drug: Linzess
1 capsule (145 mcg) of Linzess once daily for 12 weeks
Other Name: Linaclotide




Primary Outcome Measures :
  1. Change in number of daily bowel movements [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in assessment of relief [ Time Frame: 12 weeks ]
  2. Change in assessment of bowel habit [ Time Frame: 12 weeks ]
  3. Change in satisfaction with bowel habit [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239510


Locations
Layout table for location information
United States, Ohio
TriHealth
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Investigators
Layout table for investigator information
Principal Investigator: Mohd A AlSamman, MD TriHealth Inc.

Layout table for additonal information
Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02239510     History of Changes
Other Study ID Numbers: 14040
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Recruitment was low and therefore results are insufficient to share.

Keywords provided by TriHealth Inc.:
constipation
bowel habits

Additional relevant MeSH terms:
Layout table for MeSH terms
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Linaclotide
Sennoside A&B
Guanylyl Cyclase C Agonists
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Cathartics