Clinical Trial: Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II-III, Multicentre, Prospective, Exploratory, Open Label Study to Assess the Efficacy and Safety of Lanreotide Autogel 120mg in the Symptomatic Treatment of Patients With Refractory

Brief 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.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days) [ Time Frame: Day 28 ]

Original Primary Outcome: Percentage of patients having minimum reduction of 50% or normalization (≤3stools/24hours) in the mean number of stools [ Time Frame: recorded during the seven day period immediately prior to Day28 or early termination, compared to the mean of seven day period prior to baseline visit ]

Current Secondary Outcome:

• Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline [ Time Frame: Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56 ]

  SF36 QOL includes 1 multi-item scale measuring each of 8 health concepts. These scores are summed to produce raw scale scores for each health concept which are transformed to a 0-100 scale. The lower the score the more disability. The higher the score the less disability. There is in addition a single-item measure of Health Transition

  IBS-QOL is a self-report QOL measure specific to IBS that can be used to assess impact of IBS and its treatment. This consists of 34 items,each with a 5 point response scale.Individual responses to 34 items are summed and averaged for a total score and transformed to a 0-100 scale with higher scores indicating better IBS specific QOL

• Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline [ Time Frame: Baseline (day 1), day 28 and day 56 ]
  Each patient scored his/her stool on the Bristol Stool Form Scale: Type 1 - Separate hard lumps, like nuts (hard to pass); Type 2 - Sausage-shaped but lumpy; Type 3 - Like a sausage but with cracks on its surface; Type 4 - Like a sausage or snake, smooth and soft; Type 5 - Soft blobs with clear-cut edges (passed easily); Type 6 - Fluffy pieces with ragged edges, a mushy stool; Type 7 - Water no solid pieces, Entirely liquid
• Percent Change in Mean Number of Stools Compared to Baseline [ Time Frame: Baseline (Day 1), Day 28 and Day 56 ]
• Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects [ Time Frame: Baseline (Day 1), Day 28 and Day 56 ]
  Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline.
• Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools [ Time Frame: Day 56 ]

Original Secondary Outcome:

• change in QOL-Quality of Life {assess using Short Form (SF-36) and Irritable Bowel Syndrome (IBS-QOL)} compared to baseline [ Time Frame: at day 21, 28, 49 & 56 ]
• change in median score of stool consistency (Bristol stool Form Scale) [ Time Frame: recorded during the seven day period immediately prior to Day28, and Day56 or early termination compared to the mean of seven day period prior to baseline visit ]
• percent change in mean number of stools [ Time Frame: recorded during the seven day period before day28 and day56 compared to the mean of seven day period to baseline visit ]
• percentage of normalized subjects (=subjects with ≤3 stools per 24 hours) [ Time Frame: at day21, day28, day49 and day56 or at early termination visit (according to the seven day period before each considered assessment) ]
• minimum reduction of 50% or normalization (≤3 stools per 24 hours) in the mean number of stools [ Time Frame: recorded during the seven day period immediately prior to day49 or early termination compared to the mean of seven day period to baseline visit ]

Dates:
Date Received: April 30, 2009
Date Started: July 2009
Date Completion:
Last Updated: August 28, 2015
Last Verified: August 2015