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

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory Study of DSP-6952 in Patients with Irritable Bowel Syndrome with Constipation (Early Phase 2 Study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221995

Enrollment

165

Registered

2012-12-28

Start date

2012-12-26

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 who meet the RomeIII criteria for irritable bowel syndrome with constipation -Outpatients etc.

Exclusion criteria

Exclusion criteria: - Patients who have history or complication of malignancy - Patients who have history of medication allergy etc.

Design outcomes

Primary

Measure	Time frame
efficacy Stool frequency [complete spontaneous bowel movements (CSBMs) and spontaneous bowel movements (SBMs)]; intensity of abdominal pain, discomfort, bloating and straining during bowel movement; stool consistency (Bristol Stool Form Scale);adequate relief (yes / no) and global relief ; IBS Severity Index	—

Secondary

Measure	Time frame
safety Adverse events and adverse drug reactions; laboratory test values; vital signs (blood pressure and pulse rate); body weight, and body mass index (BMI); 12-lead ECG	—

Countries

Japan

Outcome results

None listed

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