Clinical trials: Polyposis
Nasal Polyps
Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma
A Phase 3b Proof-of-Concept study to evaluate the ability of fevipiprant 150 mg and 450 mg, compared with placebo, as add-on to nasal spray standard-of-care (SoC), in reducing endoscopic nasal polyp score in adult (≥ 18 years)…
- Trial name
- THUNDER (NCT03681093)
- Testing
- Fevipiprant 150 mg, Fevipiprant 450 mg
- Where
- 25 sites in United States, Argentina and 7 more
- Volunteers
- 98 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis (NEZHA-3)
This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and…
- Trial name
- NCT07807826
- Testing
- CM512
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Beijing Keymed Biosciences Co., Ltd.
Familial Adenomatous Polyposis (FAP)
Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis
The main goal of this clinical trial is to learn if the drug eRapa works to slow down the progression of disease in patients diagnosed with Familial Adenomatous Polyposis (FAP). Researchers will compare eRapa to Placebo.
- Trial name
- SERENTA (NCT06950385)
- Testing
- eRapa (encapsulated rapamycin)
- Where
- 29 sites in United States, Denmark and 5 more
- Volunteers
- 168 people
- Sponsor
- Rapamycin Holdings Inc.
Familial Adenomatous Polyposis (FAP)
Expanded Access to 0.5 mg eRapa for Familial Adenomatous Polyposis
This expanded access program provides 0.5 mg eRapa (encapsulated rapamycin) to patients with familial adenomatous polyposis (FAP) who have no satisfactory alternative treatment options and are not eligible to participate in a…
- Trial name
- eRapa-FAP (NCT07689942)
- Testing
- eRapa (encapsulated rapamycin)
- Sponsor
- Biodexa Pharmaceuticals
Chronic Sinusitis, Nasal Polyps
Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps
The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.
- Trial name
- RESOLVE (NCT01732536)
- Testing
- S8 Sinus Implant, Mometasone furoate nasal spray
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- Intersect ENT
Bilateral Nasal Polyposis
Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device
The primary objective of this study was to compare the efficacy of intranasal administration of 100, 200, and 400 μg twice daily (bid) of fluticasone propionate, delivered by the Optinose device, with matching placebo in subjects…
- Trial name
- NCT01624662
- Testing
- Fluticasone propionate
- Where
- 10 sites in United States
- Volunteers
- 323 people
- Sponsor
- Optinose US Inc.
Chronic Sinusitis, Nasal Polyposis
Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE)
The ENCORE Study is designed to evaluate the repeat administration of the S8 Sinus Implant in chronic sinusitis (CS) patients with recurrent nasal polyps.
- Trial name
- NCT03358329
- Testing
- S8 Sinus Implant
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- Intersect ENT
15q Duplication Syndrome, CDKL5 Deficiency Disease
A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)
The purpose of this study is to investigate the effect of soticlestat on the frequency of motor seizures for participants with Dup15q or CDD during the Maintenance Period.
- Trial name
- NCT03694275
- Testing
- Soticlestat
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Takeda
Familial Adenomatous Polyposis
Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)
The purpose of this randomized, double-blind, Phase III trial is to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of…
- Trial name
- NCT01483144
- Testing
- Eflornithine, Sulindac 150 MG
- Where
- 17 sites in United States, Belgium and 5 more
- Volunteers
- 171 people
- Sponsor
- Cancer Prevention Pharmaceuticals, Inc.
Nasal Polyps
Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)
This study was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps.
- Trial name
- NCT00731185
- Testing
- Mometasone Furoate Nasal Spray
- Volunteers
- 162 people
- Sponsor
- Organon and Co
Bilateral Nasal Polyposis
Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety
The primary objective of this study is to compare the efficacy of intranasal administration of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose device with placebo in subjects with bilateral…
- Trial name
- NCT01622569
- Testing
- Fluticasone Propionate
- Where
- 33 sites in United States, Canada
- Volunteers
- 323 people
- Sponsor
- Optinose US Inc.
Rhinosinusitis, Chronic Polyposis
Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi
The study should create data for the selection of a clinically relevant primary endpoint to assess the efficacy and safety of Buparid/PARI SINUS as compared to Budes Nasal Spray in the therapy of chronic rhinosinusitis (CRS) with…
- Trial name
- NCT01946711
- Testing
- Budesonide
- Where
- 4 sites in Germany
- Volunteers
- 14 people
- Sponsor
- Pari Pharma GmbH
Polyp of Ethmoidal Sinus, Surgery
RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis)
The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER® NetiFlow® device, both used postoperative care…
- Trial name
- NETIFLOW (NCT02559284)
- Testing
- A postoperative care after ethmoid sinus surgery
- Where
- 8 sites in France
- Volunteers
- 189 people
- Sponsor
- Laboratoire de la Mer
Angelman Syndrome, Chromosome 15q Duplication (dup15q) Syndrome
Angelman Syndrome (AS) Biomarker Study
The primary objective of this study is to measure ubiquitin-protein ligase E3A (UBE3A) protein levels in cerebrospinal fluid (CSF) and to evaluate its utility as a biomarker in support of the development of therapies for AS.
- Trial name
- NCT04103333
- Testing
- Lumbar Puncture, Blood Collection
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Biogen
Nasal Polyposis, Eosinophilic Chronic Rhinosinusitis
Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus…
- Trial name
- ORCHID (NCT04157335)
- Testing
- Benralizumab 30 mg
- Where
- 116 sites in United States, Argentina and 15 more
- Volunteers
- 295 people
- Sponsor
- AstraZeneca
Cancer, Colorectal Cancer
FOG-001 in Locally Advanced or Metastatic Solid Tumors
The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors or in participants with familial adenomatous polyposis (FAP).
- Conditions
- Cancer, Colorectal Cancer, Solid Tumor, Locally Advanced Solid Tumor
- Trial name
- NCT05919264
- Testing
- FOG-001, mFOLFOX-6, Nivolumab
- Where
- 33 sites in United States, Australia
- Volunteers
- 619 people
- Sponsor
- Parabilis Medicines, Inc.
Familial Adenomatous Polyposis
Trial of eRapa to Prevent Progression in Familial Adenomatous Polyposis Patients Under Active Surveillance
Patients with Familial Adenomatous Polyposis (FAP) who are undergoing endoscopic surveillance will be given Encapsulated Rapamycin (eRapa) at one of three escalating doses/schedules for 12 months with the aim of reducing polyp…
- Trial name
- NCT04230499
- Testing
- Encapsulated Rapamycin (eRapa)
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Rapamycin Holdings Inc.
Familial Adenomatous Polyposis
Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)
This is a multicenter, two-part trial in participants with FAP.
- Trial name
- TUPELO (NCT05552755)
- Testing
- REC-4881
- Where
- 17 sites in United States
- Volunteers
- 67 people
- Sponsor
- Recursion Pharmaceuticals Inc.
Familial Adenomatous Polyposis
A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP)
The purpose of this phase III study is to evaluate the safety and efficacy of the combination of eflornithine and sulindac compared to single agent sulindac or eflornithine in reducing the number of polyps in patients with…
- Trial name
- NCT01245816
- Testing
- Eflornithine plus Sulindac
- Sponsor
- Cancer Prevention Pharmaceuticals, Inc.
Bilateral Nasal Polyposis
A Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis
The study will evaluate the effect of ACT-774312 on the nasal polyps and will assess the safety and tolerability of ACT-774312 in the patients with bilateral nasal polyposis
- Trial name
- NCT03688555
- Testing
- ACT-774312
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 10 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.