Tradipitant for Nausea and Vomiting
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Vanda Pharmaceuticals
Prior Safety Data
Trial Summary
What is the purpose of this trial?The goal of this study is to measure the effects of using Tradipitant after GLP-1R agonist use on nausea and vomiting in healthy overweight, class I, or class II obese volunteers. The study is placebo-controlled with two treatment arms.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have been on any investigational medication in the past 60 days, you may not be eligible to participate.
What data supports the effectiveness of the drug Tradipitant for nausea and vomiting?
Tradipitant, a drug that blocks certain receptors involved in nausea, was shown to significantly reduce vomiting and motion sickness symptoms in a study with participants on boat trips. This suggests it could be effective for nausea and vomiting in other situations as well.
12345How does the drug Tradipitant differ from other treatments for nausea and vomiting?
Tradipitant is unique because it is a neurokinin-1 (NK1) receptor antagonist, which targets specific pathways in the brain and gut involved in nausea and vomiting. This mechanism is different from other treatments, making it potentially effective for conditions like motion sickness and gastroparesis, where traditional therapies may not provide adequate relief.
12367Eligibility Criteria
This trial is for healthy overweight individuals or those with class I or II obesity who experience nausea and vomiting after using GLP-1R agonist medications. Specific eligibility details are not provided, but typically participants must meet certain health criteria to join.Inclusion Criteria
I do not have serious health issues or diabetes.
Participant Groups
The study is testing the effectiveness of Tradipitant in reducing nausea and vomiting compared to a placebo in volunteers who have taken GLP-1R agonists. It's a controlled trial with two groups: one receiving Tradipitant and the other receiving a placebo.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tradipitant GroupExperimental Treatment1 Intervention
Treatment with tradipitant BID for approximately 2 weeks
Group II: Placebo GroupPlacebo Group1 Intervention
Treatment with placebo BID for approximately 2 weeks
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Vanda Investigational SiteLos Angeles, CA
Vanda Investigational SiteRochester, MN
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Who is running the clinical trial?
Vanda PharmaceuticalsLead Sponsor
References
Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study. [2023]Introduction: Novel therapies are needed for the treatment of motion sickness given the inadequate relief and bothersome and dangerous adverse effects of currently approved therapies. Neurokinin-1 (NK1) receptor antagonists have the potential to be effective in improving the symptoms of motion sickness, given the involvement of Substance P in nauseogenic and emetic pathways and the expression of NK1 receptors in the gastrointestinal system. Here we evaluated the efficacy of tradipitant, a novel NK1 receptor antagonist, in preventing motion sickness in variable sea conditions. Methods: A total of 126 adults participated in the Motion Sifnos study. Groups of participants were assigned to one of seven boat trips lasting ~4 h on the Pacific Ocean. Participants were randomized 1:1 to tradipitant 170 mg or placebo and completed the Motion Sickness Severity Scale (MSSS) every 30 min, in addition to other assessments. Severity of motion sickness was assessed with the incidence of vomiting and the MSSS. Results: Participants on tradipitant had a significantly lower incidence of vomiting as compared to those on placebo across all boat trips (tradipitant = 17.5%, placebo = 39.7%, p = 0.0039). For trips exposed to rough sea conditions, the difference in the incidence of vomiting between the groups was more dramatic (tradipitant = 15.79%, placebo = 72.22%, p = 0.0009). Across these trips, motion sickness symptoms were significantly lower in the tradipitant group compared to the placebo group (tradipitant = 3.19, placebo = 4.57, p = 0.0235). Discussion: Tradipitant has the potential to be an effective therapy for the prevention of vomiting and treatment of nausea in people with motion sickness.
Clinical trial: a single-centre, randomised, controlled trial of tradipitant on satiation, gastric functions, and serum drug levels in healthy volunteers. [2022]Tradipitant, an NK1 receptor antagonist, improved symptoms in patients with gastroparesis. It is unclear whether these effects are mediated centrally (e.g., vomiting centre) or on gastric functions. As a class, NK1 antagonists may retard gastric emptying (GE) or increase fasting and postprandial gastric volumes (GV).
Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy. [2019]Addition of rolapitant to standard antiemetic therapy improved protection against chemotherapy-induced nausea and vomiting (CINV) in phase 3 trials of patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC). Here, we assessed the impact of CINV on the daily lives of patients receiving HEC or MEC using the Functional Living Index-Emesis (FLIE).
Comparison of Pharmacokinetics of Aprepitant in Healthy Chinese and Caucasian Subjects. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE">Aprepitant is used to prevent nausea and vomiting associated with moderately and highly emetogenic chemotherapy. In this open-label, 2-period study, the safety, tolerability, and pharmacokinetics (PK) of aprepitant (EMEND®) were evaluated in healthy Chinese and Caucasian subjects.
Efficacy of the neurokinin-1 receptor antagonist rolapitant in preventing nausea and vomiting in patients receiving carboplatin-based chemotherapy. [2022]Rolapitant, a novel neurokinin-1 receptor antagonist, provided effective protection against chemotherapy-induced nausea and vomiting (CINV) in a randomized, double-blind phase 3 trial of patients receiving moderately emetogenic chemotherapy or an anthracycline and cyclophosphamide regimen. The current analysis explored the efficacy and safety of rolapitant in preventing CINV in a subgroup of patients receiving carboplatin.
Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial. [2021]Treatments are needed for gastroparesis; antagonists of tachykinin receptor 1 (TACR1, also called NK1R) can reduce symptoms of nausea and vomiting. We investigated the safety and efficacy of tradipitant, an antagonist of NK1R, in patients with idiopathic or diabetic gastroparesis.
Neurokinin-1-receptor antagonists: a new approach in antiemetic therapy. [2018]Aprepitant (Emend), the first neurokinin-1-receptor antagonist (NK-1-RA), represents a new class of antiemetics. Aprepitant has been approved for the prevention and treatment of acute (0-24 h after chemotherapy) and delayed (1-5 days after chemotherapy) emesis resulting from cisplatin-based chemotherapy and moderately emetogenic chemotherapy. The addition of aprepitant to standard antiemetic therapy in cisplatin-based chemotherapy significantly improves emesis protection in general and, in particular, in the delayed phase by approximately 20%. Results from a recently published study in patients receiving moderately emetogenic chemotherapy suggest a benefit of aprepitant when combined with dexamethasone and a 5-HT(3) receptor antagonist for the prevention of acute emesis, followed by aprepitant as a single agent in the prevention of delayed emesis. Altogether, the addition of aprepitant to the standard antiemetic regimen (5-HT(3) receptor antagonist and dexamethasone) significantly improves the protection against vomiting in the acute as well as in the delayed phase in highly and moderately emetogenic chemotherapies. Therefore, the combination of a 5-HT(3) receptor antagonist, dexamethasone and aprepitant should be considered as a new standard antiemetic therapy.