Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients
| Tracking Information | |||||
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| First Received Date ICMJE | December 2, 2009 | ||||
| Last Updated Date | February 1, 2013 | ||||
| Start Date ICMJE | October 2009 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percentage of responder patients. [ Time Frame: At day 7 and day 14. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01076803 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients | ||||
| Official Title ICMJE | Prospective Study to Assess the Efficacy and Safety of Lanreotide 120 mg as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients | ||||
| Brief Summary | The primary objective of this study is to assess the efficacy of Lanreotide 120 mg for the relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. This effect will be evaluated by the percentage of responder patients 7 and 14 days after one administration of lanreotide 120 mg. (A responder patient will be defined either as a patient experiencing < or= 1 vomiting episode per day during at least three consecutive days or as a patient in whom NGT has been removed without any vomiting recurrence during at least three consecutive days) The total number of visits will depend on the clinical situation, 5 visits are obligatory: Day(D)-3/-0,Day 1,Day 7,Day 14,Day 28 Inclusion visit (D-3/-0): eligibility, PIC, obstruction history, clinical exam, vital signs, diary cards, VAS scale, cc medication, blood sample Visit D1: injection Visit D7/D14/28: clinical exam, nutrition procedure, result of biochemical analyse, adverse events, cc medication In between the visits, the patient will keep and fill out his diary and VAS scale |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Malignant Intestinal Obstruction | ||||
| Intervention ICMJE | Drug: Lanreotide (acetate)
Deep subcutaneous injection into the upper external quadrant of the right or the left buttock. |
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| Study Arm (s) | Experimental: Lanreotide (acetate)
Intervention: Drug: Lanreotide (acetate) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01076803 | ||||
| Other Study ID Numbers ICMJE | 2009/289 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University Hospital, Ghent | ||||
| Study Sponsor ICMJE | University Hospital, Ghent | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Ghent | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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