Phase 3 N=42 Treatment

Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

Diarrhea

Bottom Line

View on ClinicalTrials.gov: NCT00891371 ↗

Enrolled (actual)

Serious AEs

13.9%

Results posted

Sep 2015

Primary outcome: Primary: Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days) — 44.4; 55.6 Percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: lanreotide (Autogel formulation) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ipsen
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)	44.4; 55.6	—
SECONDARY Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline	-1.3; 2.4; 2.9; 1.1; 4.5; 12.9	—
SECONDARY Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline	0.0; -0.5	—
SECONDARY Percent Change in Mean Number of Stools Compared to Baseline	-25.9; -30.7	—
SECONDARY Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects	27.5; 33.0	—
SECONDARY Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools	54.3; 45.7	—

Summary

The purpose of this study, is to assess the effect of lanreotide Autogel 120mg on stool frequency in subjects with refractory diarrhea at day 28 (mean of last 7 days) compared to baseline.

Eligibility Criteria

Inclusion Criteria

Male/female with refractory diarrhea for at least 1 month, after normal extended work-up to exclude causes of diarrhea, not or not enough responding to standard anti-diuretics as evaluated by the investigator
Patient mentally fit for completing a diary

Exclusion Criteria

Has already received a treatment with somatostatin analogues for the treatment of refractory diarrhea
Had a weight of stool < 600g in a 72hrs stool collection
Has received a treatment with laxatives within the last week before study entry
Suffers from IBS with alternating bowel habits and predominant constipation, suffers from infectious and/or inflammatory gastro-enteritis (colitis ulcerosa, crohn's disease and macroscopic colitis)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00891371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.