Clinical Trial Results:
A PHASE II, SINGLE-CENTRE, PROSPECTIVE EXPLORATORY TRIAL TO ASSESS THE EFFICACY OF LANREOTIDE AUTOGEL 120 MG IN THE SYMPTOMATIC TREATMENT OF ACUTE RADIATION INDUCED DIARRHEA
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Summary
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EudraCT number |
2016-001790-33 |
Trial protocol |
BE |
Global end of trial date |
27 Jul 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Aug 2021
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First version publication date |
11 Aug 2021
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Other versions |
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Summary report(s) |
Statement of discontinuation |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
AGO/2016/005
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Ghent University Hospital
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Sponsor organisation address |
Corneel Heymanslaan 10, Ghent, Belgium, 9000
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Public contact |
Hiruz CTU, University Hospital Ghent, 32 93320504, hiruz.ctu@uzgent.be
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Scientific contact |
Hiruz CTU, University Hospital Ghent, 32 93320504, hiruz.ctu@uzgent.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Jul 2018
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Jul 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the response (complete and/or partial) of lanreotide autogel 120 mg as add-on to loperamide 16 mg on stool frequency and loperamide intake in patients with radiation induced diarrhea not enough responding to loperamide 16 mg monotherapy compared to baseline.
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Protection of trial subjects |
Ethics review and approval, informed consent, supportive care and routine monitoring.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 99999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
99999
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
99999 is "Not applicable" value or 0 participants. | |||||||||
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Pre-assignment
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Screening details |
Inclusion criteria: • Male or female with radiation induced diarrhoea requiring daily loperamide intake (≥16mg) for at least 3 consecutive days. • Administration of lanreotide 120mg at least 7 days before ending radiotherapy. • ≤ 3 stools per 24 h before radiotherapy • > 3 stools per 24 h in the screening period. • >= 18 years • mentally fit | |||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
N/A
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Baseline arm | |||||||||
Arm description |
Baseline data for the study, as the study only has 1 arm | |||||||||
Arm type |
Baseline arm | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Treatment arm | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Somatuline Autogel Injectable 60 / 90 / 120 mg
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
-Solution for injection in pre-filled syringe
-120 mg milligram(s)
-Maximum duration of treatment of a subject according to the protocol:
1 injection at inclusion
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Baseline arm
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Reporting group description |
Baseline data for the study, as the study only has 1 arm | ||
Reporting group title |
Treatment arm
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Reporting group description |
- | ||
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End point title |
Complete response: loperamide-intake reduction of 75% or more and ≤ 3 stools per 24 hours. [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Response is assessed at day 14 (d12-14), 28 (d26-28) and 42 (d40-42) ompared to baseline (d-3 to d-1).
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis available. |
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| Notes [2] - Baseline data for the study, as the study only has 1 arm. [3] - No patients were enrolled in the study. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Partial response: loperamide-intake reduction of 50% up to 75% and ≤ 3 stools per 24 hours [4] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Response is assessed at day 14 (d12-14), 28 (d26-28) and 42 (d40-42) compared to baseline (d-3 to d-1).
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis available. |
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| Notes [5] - Baseline data for the study, as the study only has 1 arm. [6] - No patients were enrolled in the study. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Incidence of all adverse events | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
throughout the trial
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| Notes [7] - Baseline data for the study, as the study only has 1 arm. [8] - No patients were enrolled in this study. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Assessing any difference in primary or secondary (point 1 to 3) effect between patients receiving concomitant chemotherapy or not receiving chemotherapy. | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Throughout the trial
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| Notes [9] - Baseline data for the study, as the study only has 1 arm. [10] - No patients were enrolled in this study. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Timing of normalization of stools (no loperamide intake and <3/stools per 24 hours) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After ending of treatment if no complete response was reached during treatment
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| Notes [11] - Baseline data for the study, as the study only has 1 arm. [12] - No patients were enrolled in this study. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Timing of first partial and complete response | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Response is assessed at day 14 (d12-14), 28 (d26-28) and 42 (d40-42) compared to baseline (d-3 to d-1).
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| Notes [13] - Baseline data for the study, as the study only has 1 arm. [14] - No patients were enrolled in this study. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change in QOL (assess using EQ-5D-5L, EORTC QLQ-C30) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 14/28 compared to baseline
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| Notes [15] - Baseline data for the study, as the study only has 1 arm. [16] - No patients were enrolled in this study |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Overall study
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
24
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events were recorded. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| No patients were included due to the fact that there has been a sharp decrease in radiotherapy-related bowel toxicity because of improving radiotherapy techniques. | |||
