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

Novartis Pharmaceuticals64 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Peritoneal Neoplasms Intestinal Obstruction Carcinomatosis

Interventions

Octreotide LARDRUG

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

Octreotide (Immediate release)DRUG

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

methylprednisoloneDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Other protocol-defined inclusion/exclusion criteria may apply

Locations (1)

Novartis Investigative Site

Créteil, France

Outcomes

Primary Outcomes

Number of Participants With Treatment Success From Day 10 to Day 13

Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 \[from Day 10 to Day 13\] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14. Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause.

Time frame: Day 10 to Day 13

Secondary Outcomes

Number of Participants With Treatment Success From Day 5 to Day 7

Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial).

Time frame: Day 5 to Day 7

Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14

The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14.

Time frame: Day 1, Day 7 and Day 14

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 1.

Time frame: Day 1

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7

Data from ClinicalTrials.gov

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