Efficacy of Linaclotide to Senna for CIC

• Sponsor: TriHealth Inc. (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02239510
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arms: 2
• Actual Duration (Months): 21
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 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)
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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 Names: 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 Names: Linaclotide

Outcome Measures

Primary Outcome Measures

1. Change in Number of Bowel Movements Per Week [12 weeks]

   Change from before to after in number of weekly bowel movements

Secondary Outcome Measures

1. Number of Participants With Relief [12 weeks]

   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.

2. Change in Assessment of Bowel Habit [12 weeks]

   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).

3. Change in Satisfaction With Bowel Habit [12 weeks]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TriHealth	Cincinnati	Ohio	United States	45220

Sponsors and Collaborators

• TriHealth Inc.

Investigators

• Principal Investigator: Mohd A AlSamman, MD, TriHealth Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TriHealth Inc.
• ClinicalTrials.gov Identifier: NCT02239510
• Other Study ID Numbers: 14040
• First Posted: Sep 12, 2014
• Last Update Posted: Jul 2, 2019
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by TriHealth Inc.: constipation; bowel habits
• Additional relevant MeSH terms: Constipation; Linaclotide; Sennosides

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	1 week wash-out period after enrollment

Arm/Group Title	Senna	Lizness
Arm/Group Description	Patients who received Senna	Patients who received Lizness
Period Title: Overall Study
STARTED	5	4
COMPLETED	3	3
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Senna	Linzess	Total
Arm/Group Description	1 capsule (50 mg) Senna daily for 12 weeks Senna: 1 capsule (50 mg) Senna daily for 12 weeks	1 capsule (145 mcg) once daily for 12 weeks Linzess: 1 capsule (145 mcg) of Linzess once daily for 12 weeks	Total of all reporting groups
Overall Participants	3	3	6
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	2 66.7%	5 83.3%
>=65 years	0 0%	1 33.3%	1 16.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50 (14.0)	58 (10.1)	54 (11.9)
Sex: Female, Male (Count of Participants)
Female	3 100%	3 100%	6 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	3 100%	3 100%	6 100%

Outcome Measures

1. Primary Outcome

Title	Change in Number of Bowel Movements Per Week
Description	Change from before to after in number of weekly bowel movements
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senna	Lizness
Arm/Group Description	Patients who received Senna	Patients who received Lizness
Measure Participants	3	3
Mean (Standard Deviation) [weekly bowel movements]	5 (.7)	2 (2.6)

2. Secondary Outcome

Title	Number of Participants With Relief
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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senna	Lizness
Arm/Group Description	Patients who received Senna	Patients who received Lizness
Measure Participants	3	3
Count of Participants [Participants]	2 66.7%	2 66.7%

3. Secondary Outcome

Title	Change in Assessment of Bowel Habit
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).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senna	Lizness
Arm/Group Description	Patients who received Senna	Patients who received Lizness
Measure Participants	3	3
Mean (Standard Deviation) [scores on a scale]	-.20 (.20)	-.08 (.10)

4. Secondary Outcome

Title	Change in Satisfaction With Bowel Habit
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).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senna	Lizness
Arm/Group Description	Patients who received Senna	Patients who received Lizness
Measure Participants	3	3
Mean (Standard Deviation) [scores on a scale]	.23 (.32)	.03 (.21)

Adverse Events

Time Frame	16 weeks
Arm/Group Title	Senna		Linzess
Arm/Group Description	Patients who received Senna		Patients who received Linzess
All Cause Mortality
	Senna		Linzess
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)
Serious Adverse Events
	Senna		Linzess
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Senna		Linzess
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.