Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide

What Was Tested

This registered phase 1 trial tested Octreotide.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

50 actual participants took part.

It was open to women only aged from 18 years up to 65 years.

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

Examples of who could join: A positive diagnosis of IBS. Subjects must either have been surgically sterilized, hysterectomized at least 6 months prior to screening, be postmenopausal or be using a double-barrier local. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: history of or evidence for structural diseases/conditions that affect the gastrointestinal system; evidence of occult blood at stool analysis, or history of rectal bleeding; using or planning to use drugs or agents during the study period that alter gi physiology and visceral perception.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Octreotide and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2008-01 with completion listed for 2009-04.

It ran at 7 sites in United Kingdom (3), United States (2), Canada (1) and Sweden (1).

What Was Measured

Researchers chose this as the main measure: - 5 sensory pressure thresholds [mmHg] from ascending method of limits (AML) barostat protocol. - 16 sensory intensity ratings from the random phasic distention (RPD) barostat protocol (time frame: throughout the study).

It also tracked 1 secondary outcome, for example - colorectal compliance.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Octreotide in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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