Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis

What Was Tested

This registered phase 4 trial tested Oxytocin.

Based on a series of pre-clinical experiments, the investigators believe the hormone oxytoxin has both analgesic and anxiolytic properties which make it a potentially useful agent for the treatment of stress-exacerbated chronic pain syndrome such as IC.

It had two arms (groups): Oxytocin (active comparator) and Saline as a nasal spray (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

At the time of enrollment, patients will complete a series of standardized questionnaires detailing information about their IC-related symptoms at baseline as well as comorbid conditions, coping mechanisms (specifically catastrophizing), and baseline ratings of overall pain, depression, anxiety, and global functioning.

At each of these time points, the patient will be asked to report a verbal pain report, a verbal anxiety report, the number of voids since last contact with an investigator, and the use of any additional medications for pain control or anxiety.

In addition, a global response assessment (GRA) score will be obtained at 6 and 24 hours.

The patient will be asked to return within a one week period at which time he/she will receive the alternative intranasal agent.

Who Took Part

25 actual participants took part.

It was open to people of any sex aged from 19 years up to 65 years.

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

Examples of who could join: 19 - 65 years of age. Must meet the current National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) diagnostic criteria for interstitial cystitis and have some degree of continuous daily pain.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: under the age of 19; older that the age of 65; breastfeeding women.

How the Study Was Run

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

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

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant and investigator.

It started in 2010-06 with completion listed for 2015-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours (time frame: 6 and 24 hours post drug or placebo administration - the data below reflects 6 hour data).

It also tracked 1 secondary outcome, for example Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 25 people.

Its size is small, so on its own it can only give an early look.

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

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