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

Phase 2

Terminated

• Conditions: Diarrhea Predominant Irritable Bowel Syndrome
• Interventions: Drug: Placebo; Drug: Ranolazine

• Registration Number: NCT02239926
• Lead Sponsor: Mayo Clinic

Brief Summary

Will Ranolazine improve bowel function and abdominal pain in human subjects with IBS-D?

Detailed Description

This is a randomized double-blind placebo-controlled pilot study that will use validated bowel questionnaires to evaluate the effects of ranolazine administered orally twice daily in patients with diarrhea predominant IBS (IBS-D). The study will consist of a 2 week run in period, followed by 4 weeks of treatment period with oral ranolazine 1000 mg twice daily. Primary endpoint of the study will be the average Bowel Symptom Scale (BSS) scores for diarrhea and adequate relief of IBS pain and discomfort are secondary end points.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-12
• Study First Posted: 2014-09-15
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2016-01-05
• Results First Submitted QC: 2016-01-05
• Status Verified: 2016-02
• Results First Posted: 2016-02-08
• Last Update Submitted: 2016-02-16
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Ranolazine	Ranolazine	tablet, 1000 mg twice daily for four weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Diarrhea Using the Bowel Symptom Score (BSS).	baseline to 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Mean Abdominal Pain	baseline to 4 weeks	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States