Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects

What Was Tested

In this phase 3 trial, researchers set out to test Teduglutide (GLP-2 analog).

Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS).

Teduglutide is similar to a protein the body makes.

When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink.

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

The registry classes the interventions as drug.

Who Took Part

86 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: Signed and dated informed consent prior to any study-related procedures are performed. Men and women 18 years of age or older at the time of informed consent signing. Intestinal failure resulting in Short Bowel Syndrome. At least 12 months of continuous PN dependency. PN required at least 3 times weekly.

The full record lists 7 inclusion and 17 exclusion criteria; among the exclusions: participation in clinical study within 30 days for drug or 90 days for antibody; use of native glp-2 or human growth hormone (hgh) within 6 months of screening; use of iv glutamine within 30 days prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Teduglutide (GLP-2 analog) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Teduglutide (GLP-2 analog) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Teduglutide (GLP-2 analog).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-11-25 with completion listed for 2011-01-25.

It ran at 35 sites in United States (11), Canada (4), Poland (4), France (3), Germany (3) and Italy (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Responder (time frame: Weeks 20 and 24).

It also tracked 1 secondary outcome, for example Absolute Change in PN/I.V. Volume From Baseline to Last Time Point.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teduglutide (GLP-2 analog) in 86 people.

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

More context: the Teduglutide (GLP-2 analog) compound page, all human trials.