Trial Outcomes & Findings for Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With IBS-D (NCT NCT02239926)

Results Overview

BSS is a 100-mm visual analog scale for each symptom of Irritable Bowel Syndrome (IBS) (pain or discomfort, bloating, and diarrhea) with an overall severity score. Lower scores indicate symptoms are not present and higher scores indicate severe symptoms.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

5 participants

Primary outcome timeframe

baseline to 4 weeks

Results posted on

2016-03-15

Participant Flow

Subjects were enrolled at Mayo Clinic, Rochester Minnesota.

2 subjects were screen failures and were not randomized. 1 subject signed informed consent, but the study was suspended prior to that subject's randomization.

Participant milestones

Participant milestones
Measure	Ranolazine tablet, 1000 mg twice daily for four weeks	Placebo Placebo
Overall Study STARTED	0	2
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ranolazine tablet, 1000 mg twice daily for four weeks	Placebo Placebo
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With IBS-D

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranolazine tablet, 1000 mg twice daily for four weeks	Placebo n=2 Participants Placebo	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	2 participants n=7 Participants	2 participants n=5 Participants
Age, Categorical >=65 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Gender Female	—	2 participants n=7 Participants	2 participants n=5 Participants
Gender Male	—	0 participants n=7 Participants	0 participants n=5 Participants
Region of Enrollment United States	—	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 4 weeks

Population: The one subject who completed the study did not have complete data, so no analysis was performed. Study was terminated due to difficulty with enrollment.

BSS is a 100-mm visual analog scale for each symptom of Irritable Bowel Syndrome (IBS) (pain or discomfort, bloating, and diarrhea) with an overall severity score. Lower scores indicate symptoms are not present and higher scores indicate severe symptoms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to 4 weeks

Population: The one subject who completed the study did not have complete data, so no analysis was performed. Study was terminated due to difficulty with enrollment.

Daily abdominal pain intensity was rated using an 11-point (0-10) numeric rating scale, with 0 being no pain, and 10 being the worst pain imaginable. Participants were asked to rate their worst abdominal pain over the past 24 hours.

Outcome measures

Outcome data not reported

Adverse Events

Ranolazine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Yuri Saito Loftus

Mayo Clinic

Phone: 507-255-3680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place