Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2004-001091-40-FI
EUCTR2004-001091-40-FI
Active, not recruiting
Not Applicable

A Phase III, Prospective, Multicentre, Randomised, Open, Parallel Group Comparison of Lanreotide Autogel (90 and 120mg) Administered by Deep Subcutaneous Injection Every Four Weeks, with Sandostatin LAR Depot (20 and 30mg) Administered by Intramuscular Injection, Every Four Weeks for Six Months, in the Treatment of Clinical Symptoms Associated with Carcinoid Syndrome.

Beaufour Ipsen Pharma0 sites196 target enrollmentStarted: August 6, 2004Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsTreatment of clinical symptoms of carcinoid syndrome.
DrugsSomatuline Autogel 90mgSomatuline Autogel 120mgSandostatin LAR 20mgSandostatin LAR 30mg

Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Beaufour Ipsen Pharma
Enrollment
196
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •At the screening visit patients MUST satisfy all of the following criteria before they
  • •will be allowed to participate in the study:
  • •a) Male or female of 18 years of age or older.
  • •b) Histologically confirmed diagnosis of a neuroendocrine tumour of the carcinoid
  • •c) Documented evidence of carcinoid syndrome (flushing and/or diarrhoea)
  • •attributable to a primary tumour of the lung, stomach or mid\-gut
  • •d) Previous positive Octreoscan.
  • •e) World Health Organisation (WHO) performance score lower than 2 (Appendix 2 of protocol).
  • •f) Written informed consent given.
  • •At the baseline visit patients MUST satisfy the following criteria before they are randomised to receive study treatment:

Exclusion Criteria

  • •If any of the following criteria apply the patient must not enter/continue in the study:
  • •a) VIPoma or other non\-carcinoid tumour.
  • •b) Treatment with interferon, chemotherapy or radiotherapy given within 30 days
  • •prior to inclusion, or planned during the study.
  • •c) Radionuclide treatment within three months prior to inclusion, or planned during
  • •d) Presence of other active malignant pathology (except basal cellular carcinoma of
  • •the skin and/or in situ carcinoma of the cervix/uterus).
  • •e) Surgical procedure or embolisation procedure (with or without cytotoxic agents)
  • •of the tumour within three months prior to inclusion, or planned during the
  • •f) Patient is pregnant, lactating, or not taking adequate precautions against

Investigators

Sponsor
Beaufour Ipsen Pharma

Similar Trials

Recruiting
Phase 3
Modafinil In Debilitating Fatigue After Stroke 2(MIDAS 2)Post Stroke FatigueStroke - HaemorrhagicStroke - Ischaemic
ACTRN12618000602224The Florey Institute of Neuroscience and Mental Health (The Florey)300
Active, not recruiting
Phase 1
Clinical research study to investigate efficacy and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Double Lung TransplantationMedDRA version: 20.0Level: LLTClassification code 10049202Term: Bronchiolitis obliteransSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
EUCTR2018-003205-25-DKZambon SpA170
Active, not recruiting
Phase 1
Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndromeafter double lung transplantation.Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Double Lung TransplantationTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
EUCTR2018-003205-25-ATZambon SpA170
Active, not recruiting
Phase 1
Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndromeafter double lung transplantation.Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Double Lung TransplantationTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
EUCTR2018-003205-25-BEZambon SpA170
Active, not recruiting
Phase 1
Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.Bronchiolitis Obliterans Syndrome in Patients post Double Lung TransplantationTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
EUCTR2018-003205-25-ESBREATH Therapeutics Inc.110