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EFFICACY OF ORAL SODIUM CROMOGLICATE IN THE IRRITABLE BOWEL SYNDROME: A DOUBLE BLIND PLACEBO CONTROLLED MULTICENTRE RANDOMISED STUDY

EFFICACY OF ORAL SODIUM CROMOGLICATE IN THE IRRITABLE BOWEL SYNDROME: A DOUBLE BLIND PLACEBO CONTROLLED MULTICENTRE RANDOMISED STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003625-46-IT
Enrollment
Unknown
Registered
2007-06-27
Start date
2006-03-28
Completion date
Unknown
Last updated
2013-03-18

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

Conditions

IRRITABLE BOWEL SYNDROME MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: NALCROM*OS GRAT 6BUST 500MG Pharmaceutical Form: Granules INN or Proposed INN: Cromoglicic acid CAS Number: 15826-37-6 Concentration unit: mg milligram(s) Concentration number: 500- Pharma

Sponsors

ITALCHIMICI SPA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with IBS symptons (according to ROMA II) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with previously surgical treatment of abdomen; use of intestinal drug (motility)

Design outcomes

Primary

MeasureTime frame
Main Objective: EFFICACY OF SCG IN IBS;Secondary Objective: Severity and frequency of symptons inn subgroup of patients with mast cells infiltration of the cholic mucosa.;Primary end point(s): Improvement of symptoms in 50% of patients, during treatment—

Countries

Czech Republic, Italy, Poland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026