Trial Outcomes & Findings for Efficacy of Linaclotide to Senna for CIC (NCT NCT02239510)

Results Overview

Change from before to after in number of weekly bowel movements

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-07-02

Participant Flow

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.

1 week wash-out period after enrollment

Participant milestones

Participant milestones
Measure	Senna Patients who received Senna	Lizness Patients who received Lizness
Overall Study STARTED	5	4
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Senna Patients who received Senna	Lizness Patients who received Lizness
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Efficacy of Linaclotide to Senna for CIC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Senna n=3 Participants 1 capsule (50 mg) Senna daily for 12 weeks Senna: 1 capsule (50 mg) Senna daily for 12 weeks	Linzess n=3 Participants 1 capsule (145 mcg) once daily for 12 weeks Linzess: 1 capsule (145 mcg) of Linzess once daily for 12 weeks	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 14.0 • n=5 Participants	58 years STANDARD_DEVIATION 10.1 • n=7 Participants	54 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Change from before to after in number of weekly bowel movements

Outcome measures

Outcome measures
Measure	Senna n=3 Participants Patients who received Senna	Lizness n=3 Participants Patients who received Lizness
Change in Number of Bowel Movements Per Week	5 weekly bowel movements Standard Deviation .7	2 weekly bowel movements Standard Deviation 2.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Senna n=3 Participants Patients who received Senna	Lizness n=3 Participants Patients who received Lizness
Number of Participants With Relief	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Senna n=3 Participants Patients who received Senna	Lizness n=3 Participants Patients who received Lizness
Change in Assessment of Bowel Habit	-.20 scores on a scale Standard Deviation .20	-.08 scores on a scale Standard Deviation .10

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Senna n=3 Participants Patients who received Senna	Lizness n=3 Participants Patients who received Lizness
Change in Satisfaction With Bowel Habit	.23 scores on a scale Standard Deviation .32	.03 scores on a scale Standard Deviation .21

Adverse Events

Senna

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Linzess

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jenni Steinbrunner

TriHealth Hatton Research Institute

Phone: 513-862-4033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place