Sandostatin® in the treatment of diarrhea in patients with ileal pouch anal anastomosis. - pouchitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005642-37-BE

Enrollment

Registered

2007-03-06

Start date

2007-04-10

Completion date

Unknown

Last updated

2021-04-12

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

Conditions

IPAA Pouchitis

Interventions

Trade Name: Sandostatine 0,5mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: OCTREOTIDE CAS Number: 83150769 Concentration unit: mg/ml milligram(s)/millilitre Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with IPAA, who have had a functioning pouch without ileostomy for at least 6 months. - A stool frequency of 7 or more loose stools in 24 hrs. for at least 7 consecutive days prior to inclusion. - Stable dose of loperamide or antibiotics for at least 7 days prior to inclusion. Are the trial subjects under 18? no Number of subjects for this age range: 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: - Evidence of ongoing or recent (within 14 days) enteritis or positive stool culture for enteric pathogens or C difficile toxin positivity. - Short bowel syndrome. - Pouch related fistula or stenosis of pouch outlet. - Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control. - Known allergy to Sandostatin? or one of its compounds. - Symptomatic cholelithiasis - Poorly controlled Diabetes Mellitus : Hba1c > 10 %.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy and safety of subcutaneous Sandostatin and intramuscular Sandostatin LAR in the treatment of diarrhea in patients with IPAA.;Secondary Objective: -Proportion of patients with clinical response after 14 days in the induction phase and after 3 months and 6 months in the maintenance phase. - Proportion of patients with durable response over 3 months and 6 months. -Change in quality of life index (SF-36). -Tolerance and safety of Sandostatin® in the induction and maintenance treatment. -Changes in Cleveland Clinic pouchitis activity score including endoscopic appearance. ;Primary end point(s): The proportion of patients responding to the induction treatment at day 7. Response is defined • as a decrease in stool frequency with 3 or more bowel movements per 24 hrs (if the daily number of stools at inclusion was 9 or less) or • as a decrease in stool frequency with at least 30% of the daily number of stools at inclusion (if the daily number of stools at inclusion was 10 or more).	—

Measure

Time frame

Main Objective: To investigate the efficacy and safety of subcutaneous Sandostatin and intramuscular Sandostatin LAR in the treatment of diarrhea in patients with IPAA.;Secondary Objective: -Proportion of patients with clinical response after 14 days in the induction phase and after 3 months and 6 months in the maintenance phase. - Proportion of patients with durable response over 3 months and 6 months. -Change in quality of life index (SF-36). -Tolerance and safety of Sandostatin® in the induction and maintenance treatment. -Changes in Cleveland Clinic pouchitis activity score including endoscopic appearance. ;Primary end point(s): The proportion of patients responding to the induction treatment at day 7. Response is defined • as a decrease in stool frequency with 3 or more bowel movements per 24 hrs (if the daily number of stools at inclusion was 9 or less) or • as a decrease in stool frequency with at least 30% of the daily number of stools at inclusion (if the daily number of stools at inclusion was 10 or more).

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Countries

Belgium

Outcome results

None listed

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