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Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis

NCT ID: NCT00332696

Last Updated: 2011-09-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-09-30

Brief Summary

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To evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel obstruction in patients with peritoneal carcinomatosis

Detailed Description

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Conditions

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Peritoneal Neoplasms Intestinal Obstruction Carcinomatosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Octreotide

Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Group Type EXPERIMENTAL

Octreotide LAR

Intervention Type DRUG

Octreotide long-acting release (LAR) 30 mg intramuscular injection.

Octreotide (Immediate release)

Intervention Type DRUG

Immediate-release Octreotide supplied in 100 µg/mL ampules.

methylprednisolone

Intervention Type DRUG

methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).

Placebo

Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Group Type PLACEBO_COMPARATOR

methylprednisolone

Intervention Type DRUG

methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).

Placebo

Intervention Type DRUG

Physiologic saline solution

Interventions

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Octreotide LAR

Octreotide long-acting release (LAR) 30 mg intramuscular injection.

Intervention Type DRUG

Octreotide (Immediate release)

Immediate-release Octreotide supplied in 100 µg/mL ampules.

Intervention Type DRUG

methylprednisolone

methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).

Intervention Type DRUG

Placebo

Physiologic saline solution

Intervention Type DRUG

Other Intervention Names

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Sandostatin® LAR Sandostatin®

Eligibility Criteria

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Inclusion Criteria

* Patients with symptoms and signs of inoperable bowel obstruction confirmed by a surgeon or clinic and radiographic assessment (CT scan or at least abdominal X-ray);
* Confirmed peritoneal carcinomatosis (with one of the following criteria : surgery, imaging and/or cytology);
* No corticotherapy at dose more than 1mg/kg equivalent-methylprednisolone, in the previous 2 weeks ;
* No chemotherapy in the previous week;
* No radio or chemotherapy planned at the inclusion and within the two weeks following inclusion
* Authorized concomitant treatments for local standard medical care : antiemetics, antispasmodics, anti-Histamine2 (H2) drugs blockers or proton pump inhibitor, analgesics; nasogastric tube

Exclusion Criteria

* Abnormal coagulation (prothrombin time \< 60%, platelets \< 50x10\^9/L).
* Non authorized concomitant treatments :

1. Anticholinergics such as scopolamine
2. Other somatostatin analogues
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Créteil, , France

Site Status

Countries

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France

Other Identifiers

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CSMS995AFR08

Identifier Type: -

Identifier Source: org_study_id