Clinical trials: Polyposis
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.
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
Dup15q Syndrome
A Study to Evaluate the Safety and Efficacy of Basmisanil Treatment in Children Aged 2-14 Years With Dup15q Syndrome
This study consists of two parts. Part 1 will evaluate the safety, efficacy, and pharmacodynamics of 52-weeks of basmisanil treatment in children and adolescents (aged 2-14 years) with Dup15q syndrome.
- Trial name
- NCT05307679
- Testing
- Basmisanil
- Where
- 5 sites in United States, Spain and 1 more
- Volunteers
- 7 people
- Sponsor
- Hoffmann-La Roche
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
Familial Adenomatous Polyposis (FAP)
Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients
This is a registry-based observational study assessing clinical outcomes in FAP patients receiving celecoxib compared with historical/concurrent registry patients who have not received celecoxib.
- Trial name
- NCT00151476
- Testing
- Celecoxib, Routine Medical Care
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 68 people
- Sponsor
- Pfizer
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
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.
Nasal Polyposis
Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis
The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with…
- Trial name
- OSTRO (NCT03401229)
- Testing
- Benralizumab 30 mg SC + Mometasone Furoate
- Where
- 99 sites in United States, Austria and 6 more
- Volunteers
- 413 people
- Sponsor
- AstraZeneca
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.
Adenomatous Polyposis Coli
Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)
To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).
- Trial name
- CHIP (NCT00585312)
- Testing
- Celecoxib
- Where
- 42 sites in United States, Belgium and 12 more
- Volunteers
- 106 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Nasal Polyposis
Study to Evaluate Multiple Doses in Patients With Nasal Polyposis
This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.
- Trial name
- NCT02734849
- Testing
- AK001 low dose, AK001 high dose
- Where
- 15 sites in United States, Belgium and 4 more
- Volunteers
- 40 people
- Sponsor
- Allakos Inc.
Nasal Polyposis
Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video
This is a 24-week, open-label, multi-center study designed to assess the efficacy and safety of OPN-375 186 μg twice a day in subjects with nasal polyps using Nasoendoscopic video.
- Trial name
- NCT03591068
- Testing
- Fluticasone Propionate
- Where
- 2 sites in United States
- Volunteers
- 11 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
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.
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
S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps
The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.
- Trial name
- RESOLVE_II (NCT02291549)
- Testing
- S8 Sinus Implant, Mometasone furoate nasal spray
- Where
- 40 sites in United States
- Volunteers
- 300 people
- Sponsor
- Intersect ENT
Rectal Cancer, Ulcerative Colitis
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement…
- Conditions
- Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis, Diverticulitis
- Trial name
- NCT00663819
- Testing
- GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement, Staple line without reinforcement
- Where
- 16 sites in United States
- Volunteers
- 258 people
- Sponsor
- W.L.Gore & Associates
Ulcerative Colitis, Familial Polyposis
An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery
This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of…
- Trial name
- NCT01002287
- Testing
- SprayShield Adhesion Barrier System, Good Surgical Technique Alone
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Integra LifeSciences Corporation
Familial Adenomatous Polyposis Coli, FAP
Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Using EPA
This purpose of this study is to investigate whether the number and size of rectal polyps can be reduced in patients with Familial Adenomatous Polyposis (FAP) by using a highly-purified form of a naturally occurring substance…
- Trial name
- NCT00510692
- Testing
- Eicosapentanoic Acid (EPA), Endoscopy, Biopsies taken
- Where
- United Kingdom
- Volunteers
- 58 people
- Sponsor
- S.L.A. Pharma AG