Phase 3
Completed N=42
Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea
Source: ClinicalTrials.gov NCT00891371 ↗Enrolled (actual)
42
Serious AEs
13.9%
Results posted
Sep 2015
Primary outcomePrimary: 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
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.
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 | — |
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)
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. Informational only — not medical advice.