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

What Was Tested

This registered phase 2 trial tested Octreotide.

It had two arms (groups): Octreotide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 64 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 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.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: non authorized concomitant treatments :; anticholinergics such as scopolamine; other somatostatin analogues.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

The Octreotide group and the comparison group ran side by side rather than switching.

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2005-09 with completion listed for 2008-09.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Treatment Success From Day 10 to Day 13 (time frame: Day 10 to Day 13).

It also tracked 10 secondary outcomes, for example Number of Participants With Treatment Success From Day 5 to Day 7, Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14, Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1, Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7, Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 and Number of Participants With Relief From Obstruction at Day 7 and Day 14.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 64 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Octreotide compound page, all human trials.