The trial team found telotrisat etpirate with somatostatin analogues helped people with diarrhoea caused by carcinoid syndrome.
About this trial
This was a phase 3 trial. It was a randomised, double blind trial. Everyone was put into 1 of 3 groups. Neither they nor their doctor chose or knew which group they were in.
76 people took part in the trial.
- 25 people had low dose of telotrisat etpirate
- 25 people had a high dose of telotrisat etpirate
- 26 people had a dummy drug (placebo
)
Everyone had 12 weeks of treatment. This was the double blind part of the trial. After this the team told everyone which group they were in.
They then had the choice to continue with telotrisat epitrate at the high dose for another 36 weeks. This is called the open label extension period.
Results
Before starting treatment everyone collected their urine for 24 hours. The team looked at the amount of a chemical called u5-HIAA in the urine. This chemical is made as part of the process of breaking down serotonin. Our body gets rid of it in urine.
After 12 weeks of treatment people collected their urine again for 24 hours. The team looked at the difference in the amount of u5-HIAA between these 2 urine collections.
The team found that there was a statically significant difference in the level of u5-HIAA in both groups who had telotrisat epitrate compared with the dummy drug group. And for the majority of people this continued into the open label extension period.
The team compared the symptoms of carcinoid syndrome people had in each group. They found that the form and firmness of the poo was significantly better for those who had telotrisat epitrate.
Side effects
Most side effects were mild or moderate. People who had telotrisat epitrate reported more side effects than those who had the dummy drug.
The most common side effects were:
- feeling or being sick
- diarrhoea or constipation
- tummy (abdominal) pain or discomfort
- bloating of the tummy
- indigestion
Conclusion
The team concluded that treatment with telotrisat epitrate for up to 48 weeks:
- was acceptable
- had few side effects
- had a lasting decrease in the level of u5-HIAA
These results plus the results of the TELESTAR trial support the use of telotrisat epitrate with somatostatin analogues in people with diarrhoea caused by carcinoid syndrome.
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
