Befejeződött3. fázis
Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
A legfontosabb adatok
- Ki végzi
- Vanda Pharmaceuticals
- Hol
- Birmingham, Boston, Brooklyn, Charlotte, Chattanooga, Chesterfield, Chevy Chase, Chula Vista, Columbus, Edmond, Houston, Huber Heights, La Jolla, Las Vegas, Little Rock, Los Angeles, Louisville, Maitland, Marrero, Morrow, Nashville, Palmetto Bay, Peoria, Philadelphia, Plano, Raleigh, Salt Lake City, San Antonio, Tampa, Tulsa, Wauconda, West Des Moines és Wichita (Egyesült Államok)Mind a 33 helyszín megnézése
- Azonosító
- Állapot
- Befejeződött
- Fázis
- 3. fázis
- Résztvevők
- 979 fő vett részt
- Kezdés
- 2019. aug. 20.
- Befejezés
- 2025. febr. 21.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
- A vizsgált kezelések
- Tradipitant
- Placebo
- Open Label Tradipitant
- A regiszteradat frissítve
- 2026. szeptember 24.
Ki vehet részt
- Életkor
- 18 év – 70 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 8 feltétel megnézéseKevesebb
Ki vehet részt
- Diagnosed with gastroparesis
- Demonstrated delayed gastric emptying
- Presence of moderate to severe nausea
- Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
Ki nem vehet részt
- A positive test for drugs of abuse at the screening or evaluation visits
- Exposure to any investigational medication in the past 60 days
- Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
- Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis
Helyszínek itt: Egyesült Államok
- Birmingham, AlabamaHospital not named in the registry
- Boston, MassachusettsHospital not named in the registry
- Brooklyn, New YorkHospital not named in the registry
- Charlotte, North CarolinaHospital not named in the registry
- Chattanooga, TennesseeHospital not named in the registry
- Chesterfield, MissouriHospital not named in the registry
- Chevy Chase, MarylandHospital not named in the registry
- Chula Vista, CaliforniaHospital not named in the registry
- Columbus, OhioHospital not named in the registry
- Edmond, OklahomaHospital not named in the registry
- Houston, TexasHospital not named in the registry
- Huber Heights, OhioHospital not named in the registry
- La Jolla, CaliforniaHospital not named in the registry
- Las Vegas, NevadaHospital not named in the registry
- Little Rock, ArkansasHospital not named in the registry
- Los Angeles, CaliforniaHospital not named in the registry
- Louisville, KentuckyHospital not named in the registry
- Maitland, FloridaHospital not named in the registry
- Marrero, LouisianaHospital not named in the registry
- Morrow, GeorgiaHospital not named in the registry
- Nashville, TennesseeHospital not named in the registry
- Palmetto Bay, FloridaHospital not named in the registry
- Peoria, ArizonaHospital not named in the registry
- Philadelphia, PennsylvaniaHospital not named in the registry
- Plano, TexasHospital not named in the registry
- Raleigh, North CarolinaHospital not named in the registry
- Salt Lake City, UtahHospital not named in the registry
- San Antonio, TexasHospital not named in the registry
- Tampa, FloridaHospital not named in the registry
- Tulsa, OklahomaHospital not named in the registry
- Wauconda, IllinoisHospital not named in the registry
- West Des Moines, IowaHospital not named in the registry
- Wichita, KansasHospital not named in the registry
A vizsgálatról
Mit akar kideríteni a vizsgálat
To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.
A vizsgálat 3 csoportja
- TradipitantA vizsgált kezelés
Oral Capsule
- PlaceboPlacebo, összehasonlításként
Oral Capsule
- Open Label TradipitantA vizsgált kezelés
Oral Capsule
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- VP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Iii Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis
- Publikációk
- The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2024
- A regiszteradat frissítve
- 2026. szeptember 24.