Testing the Safety and Efficacy of Tradipitant for Patients with Diabetic and Idiopathic Gastroparesis

by Danielle Bradshaw from In The Cloud Copy

Gastroparesis is a condition in which your stomach’s muscles aren’t able to completely move food through your stomach. Symptoms of gastroparesis include nausea, acid reflux, abdominal pain, abdominal bloating, lack of appetite, fluctuations in blood sugar, and vomiting. It can be caused by either diabetes or by taking certain medications (also known as idiopathic gastroparesis).

Needless to say, this condition needs some form of treatment. Antagonists of tachykinin receptor 1 (TACR1 or NK1R) are medications that have the potential to alleviate nausea and vomiting. To ensure that tradipitant, one of many types of the aforementioned “antagonists”, is safe and useful in treating both types of gastroparesis, a trial study was conducted in 2016 to determine the drug’s effectiveness.

The Study Methods

The study was done in a double-blind trial, meaning neither the patients nor the researchers know who’s getting the actual medication or a placebo. 152 adults that had gastroparesis from 47 locations around the US were gathered in November 2016 all the way through December 2018. Each participant was placed into two randomly assembled groups and given either an 85mg oral tradipitant or a placebo. 77 people were given the former and 75 received the latter.

The researchers gave the two groups a diary so that they could measure their symptoms daily. With this diary, along with a gastroparesis cardinal symptom index scoring system and other accompanying questionnaires completed by the patients, the research team was able to assess how well the tradipitant was working to control symptoms.

The Study’s Results

Overall, the participants of the study that were given tradipitant saw a decrease in nausea (their nausea scores from the scoring system was lowered by 1.2) at around 4 weeks as opposed to the patients that were given the placebo (who had a reduction of 0.7). By week four, the participants had more nausea-free days as well (the tradipitant patients had a 28.8% increase and the placebo patients had a 15.0% increase).

Anyone that suffered from vomiting and nausea at the beginning (101 patients) saw that their nausea decreased when they had been given tradipitant (a 1.4 score reduction) whereas the placebo patients had a decrease of only 0.4. This particular set of patients also experienced an increased number of nausea-free days – those who were taking the tradipitant had a 32.2% improvement versus the 7.6% increase with the placebo.

32.3% of the patients taking tradipitant had an average nausea score of 1 or lower around the 4th week and 11.8% of the participants on the placebo saw the same results. Gastroparesis improvement was 1 or more points higher on the symptom index for 46.6% of tradipitant participants in comparison to the 23.5% of placebo patients.

In conclusion, it was found that tradipitant is able to both safely and effectively reduce vomiting and nausea in patients with diabetic and idiopathic gastroparesis.

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