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.

• Conditions: Treatment of clinical symptoms of carcinoid syndrome.

• Registration Number: EUCTR2004-001091-40-FI
• Lead Sponsor: Beaufour Ipsen Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 196

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
type
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:
g) Stool and/or flushing frequency of =3 episodes/day (average over a minimum
five consecutive days).
h) Patients who have previously been treated with somatostatin analogues must
have discontinued treatment for a sufficient period of time (a washout period of
at least 7 days for immediate release formulations and up to 2 months for
prolonged release formulations is usually required). Compared with their
controlled state on treatment, these patients must show a clinically significant
deterioration (at least two episodes) of either symptom. For example, a patient
considered to be controlled on their previous treatment with an estimated stool
frequency of two episodes per day, must achieve a stool frequency of at least
four episodes per day (average over a minimum five consecutive days).
i) WHO performance score lower than 2 (Appendix 2 of protocol).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
the study.
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
study.
f) Patient is pregnant, lactating, or not taking adequate precautions against
pregnancy. (NB Patients of childbearing potential must demonstrate a negative
serum pregnancy test, and be using appropriate double methods of contraception, such as approved hormonal contraceptives or a condom used with a spermicide).
g) Life expectancy of less than 6 months.
h) Known hypersensitivity to any of the test materials or related compounds.
i) Any investigational drug given within 30 days prior to inclusion or expected to be given during the study.
j) Previous participation in this study.
k) No access to a telephone for completion of the daily telephone diary.
l) In the opinion of the investigator the patient is unable and/or unwilling to
comply fully with the protocol and the study instructions.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified