Trial · Interventional

TerminatedNot applicableResults postedRegistry data

Efficacy of Linaclotide to Senna for CIC

NCTNCT02239510Other id14040

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Not sufficient recruitment

Results were posted for this trial.

Overview

Status: Terminated
Phase: Not applicable
Enrollment: 9 participants (actual)
Sponsor: TriHealth Inc. · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Sept 2014
Primary completion: Jun 2016
Completion: Jun 2016
First posted: 12 Sept 2014 (estimated)
Last update posted: 2 Jul 2019
Conditions: Chronic Idiopathic Constipation

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2014201520162017

N/A
Efficacy of Linaclotide to Senna for CIC
NCT02239510
Sept 2014 to Jun 2016
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

SennaDrug
LinzessDrug

Arms2

Active comparator
Senna
1 capsule (50 mg) Senna daily for 12 weeks
Active comparator
Linzess
1 capsule (145 mcg) once daily for 12 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Number of Bowel Movements Per Week
Time frame · 12 weeks
Registry description
Change from before to after in number of weekly bowel movements

Secondary outcomes(3)

Number of Participants With Relief
Time frame · 12 weeks
Registry description
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
Time frame · 12 weeks
Registry description
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
Time frame · 12 weeks
Registry description
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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 12 weeks

Change in Number of Bowel Movements Per Week

Group	Value (weekly bowel movements)	Spread
Senna	5	.7
Lizness	2	2.6

Secondary and other outcome results(3)

Secondary outcomeCount of participants· 12 weeks

Number of Participants With Relief

Group	Value (Participants)
Senna	2
Lizness	2

Secondary outcomeMean· 12 weeks

Change in Assessment of Bowel Habit

Group	Value (scores on a scale)	Spread
Senna	-.20	.20
Lizness	-.08	.10

Secondary outcomeMean· 12 weeks

Change in Satisfaction With Bowel Habit

Group	Value (scores on a scale)	Spread
Senna	.23	.32
Lizness	.03	.21

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
SennaPatients who received Senna	0 / 5	0 / 5	0 / 5
LinzessPatients who received Linzess	0 / 4	0 / 4	0 / 4

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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)

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