Dose-finding Study of DSP-6952 in Patients with Irritable Bowel Syndrome with Constipation

A Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-finding Study of DSP-6952 in Patients with Irritable Bowel Syndrome with Constipation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223404

Enrollment

400

Registered

2016-12-06

Start date

2017-01-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable bowel syndrome with constipation

Interventions

investigational material(s) Generic name etc : DSP-6952 INN of investigational material : minesapride Therapeutic category code : 2-- Agents affecting individual organs Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with irritable bowel syndrome based on the Rome IV diagnostic citeria and who met the criteria for the constipation type based on their bowel movements - Outpatients etc.

Exclusion criteria

Exclusion criteria: - Patients with a history or complication of malignant tumors - Patients with a history of drug allergy etc.

Design outcomes

Primary

Measure	Time frame
efficacy Responder rate for bowel movement and abdominal pain improvement	—

Secondary

Measure	Time frame
efficacy - Efficacy Endpoints: Number of bowel movements (CSBMs and SBMs), straining during bowel movement, stool consistency and abdominal symptoms (ie, abdominal pain, abdominal discomfort, and abdominal bloating), IBS-C symptoms, IBS severity index Japanese version, IBS quality of life measure Japanese version, Euro-QOL 5 Dimensions-5 Levels Japanese version safety - Safety Endpoints: Adverse events and adverse drug reactions, Diarrhoea as an adverse event, Laboratory test values, Vital signs, body weight, and BMI, 12-lead ECG pharmacokinetics - Pharmacokinetic Endpoint: Plasma concentration of DSP-6952	—

Measure

Time frame

efficacy - Efficacy Endpoints: Number of bowel movements (CSBMs and SBMs), straining during bowel movement, stool consistency and abdominal symptoms (ie, abdominal pain, abdominal discomfort, and abdominal bloating), IBS-C symptoms, IBS severity index Japanese version, IBS quality of life measure Japanese version, Euro-QOL 5 Dimensions-5 Levels Japanese version safety - Safety Endpoints: Adverse events and adverse drug reactions, Diarrhoea as an adverse event, Laboratory test values, Vital signs, body weight, and BMI, 12-lead ECG pharmacokinetics - Pharmacokinetic Endpoint: Plasma concentration of DSP-6952

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026