Clinical trials: Intestinal Disease
Neoplasms
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: has spread to other parts of the…
- Trial name
- NCT04607421
- Testing
- Encorafenib, Cetuximab, Oxaliplatin
- Where
- 272 sites in United States, Argentina and 27 more
- Volunteers
- 841 people
- Sponsor
- Pfizer
Fecal Incontinence
Effects of an Anal Insert Device in Fecal Incontinence
The purpose of this research is to test the effects of an inserted anal device on fecal incontinence (accidental bowel leakage) in patients who have persistent symptoms despite other conservative therapy.
- Trial name
- NCT03898778
- Testing
- Minnesota Medical Technologies Anal Insert Device
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Minnesota Medical Technologies
Eosinophilic Gastritis, Eosinophilic Gastroenteritis
Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
This is a 3-part study. Part A is randomized, double-blinded, placebo-controlled and includes patients with eosinophilic gastritis and/or duodenal-only disease.
- Trial name
- HUDSON GI (NCT05251909)
- Testing
- Benralizumab
- Where
- 20 sites in United States, Brazil and 7 more
- Volunteers
- 12 people
- Sponsor
- AstraZeneca
RET-altered Non Small Cell Lung Cancer, Medullary Thyroid Cancer
Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667)…
- Conditions
- RET-altered Non Small Cell Lung Cancer, Medullary Thyroid Cancer, RET-altered Papillary Thyroid Cancer, RET-altered Colon Cancer
- Trial name
- ARROW (NCT03037385)
- Testing
- pralsetinib (BLU-667)
- Where
- 71 sites in United States, Belgium and 11 more
- Volunteers
- 590 people
- Sponsor
- Hoffmann-La Roche
Intestinal Diseases
Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions
The goal of this study is to compare two formulations of Albendazole of the same dose in healthy adult participants. Researchers will compare the extent and rate to which the drug is absorbed.
- Trial name
- NCT06201559
- Testing
- Albendazole IP 400 mg, Albendazole 400 mg
- Where
- India
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Ileus, Gastro-Intestinal Disorder
A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.
- Trial name
- INTEGRITY (NCT05470387)
- Testing
- LB1148
- Where
- 23 sites in United States
- Volunteers
- 23 people
- Sponsor
- Palisade Bio
Colorectal Cancer
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine…
- Trial name
- NCT00838578
- Testing
- KRN330, Irinotecan
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Ulcerative Colitis, Digestive System Diseases
Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC)…
- Conditions
- Ulcerative Colitis, Digestive System Diseases, Colitis, Ulcerative, Colitis
- Trial name
- NCT02647866
- Testing
- KHK4083
- Where
- 23 sites in United States, Czechia and 5 more
- Volunteers
- 66 people
- Sponsor
- Kyowa Kirin, Inc.
Fecal Incontinence
Autologous Cell Therapy for Treatment of Fecal Incontinence
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment…
- Trial name
- NCT01600755
- Testing
- Iltamiocel
- Where
- 2 sites in Canada, United Kingdom
- Volunteers
- 53 people
- Sponsor
- Cook MyoSite
Colorectal Cancer
A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer
This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in…
- Trial name
- CanStem303C (NCT02753127)
- Testing
- Napabucasin, Fluorouracil, Leucovorin
- Where
- 211 sites in United States, Australia and 14 more
- Volunteers
- 1,253 people
- Sponsor
- Sumitomo Pharma America, Inc.
Neoplasms, Colorectal Neoplasms
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
This study will evaluate the efficacy and safety of alectinib in participants with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic solid tumors other than lung cancer.
- Conditions
- Neoplasms, Colorectal Neoplasms, Melanoma, Pancreatic Neoplasms
- Trial name
- ALpha-T (NCT04644315)
- Testing
- Alectinib
- Where
- 29 sites in United States
- Volunteers
- 1 people
- Sponsor
- Hoffmann-La Roche
Clostridioides Difficile Infection
ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection
Cohort 1: Subjects who had a Clostridioides difficile infection (CDI) recurrence in study SERES-012 within 8 weeks of receipt of study drug will be eligible.
- Trial name
- NCT03183141
- Testing
- SER-109
- Where
- 107 sites in United States, Canada
- Volunteers
- 263 people
- Sponsor
- Seres Therapeutics, Inc.
Crohn's Disease, Inflammatory Bowel Disease
An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.
- Trial name
- NCT01009281
- Testing
- AIN457
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Inflammatory Bowel Diseases, Skin Extra-intestinal Manifestations
Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients With Active Skin Extra-intestinal Manifestations
The purpose of this phase 2a, proof of concept, open-label clinical study is to evaluate the efficacy and safety of etrasimod (APD334) in inflammatory bowel disease patients with active skin extra-intestinal manifestations.
- Trial name
- NCT03139032
- Testing
- APD334
- Where
- 3 sites in Belgium, Germany and 1 more
- Volunteers
- 1 people
- Sponsor
- Arena Pharmaceuticals
Anemia, Iron-Deficiency, Inflammatory Bowel Disease
Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD
The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with…
- Conditions
- Anemia, Iron-Deficiency, Inflammatory Bowel Disease, Crohn's Disease
- Trial name
- NCT02680756
- Testing
- Ferric Maltol, Ferric Carboxy Maltose
- Where
- 44 sites in United States, Belgium and 4 more
- Volunteers
- 250 people
- Sponsor
- Shield Therapeutics
Colonic Diseases, Bowel Diseases
Evaluation of PillCam™ Colon 2 in Visualization of the Colon
To evaluate the performance of PillCam COLON 2 in regards to detection of patients with polyps where colonoscopy is considered as the gold standard reference.
- Trial name
- NCT01087528
- Testing
- PillCam™ (Capsule Endoscopy) Colon 2 capsule
- Where
- 4 sites in United States
- Volunteers
- 51 people
- Sponsor
- Medtronic - MITG
Colonic Neoplasms
PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer
The purpose of this study is to compare the concentration of four different metabolites in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different doses of Modufolin (arfolitixorin) and…
- Trial name
- NCT01681472
- Testing
- 6R-MTHF (arfolitixorin) 200 mg/m2, Levoleucovorin 200 mg/m2, 6R-MTHF (arfolitixorin) 60 mg/m2
- Where
- Sweden
- Volunteers
- 32 people
- Sponsor
- Isofol Medical AB
Fecal Incontinence, Bowel Dysfunction
LIBERATE - PRO: Eclipse™ System Registry
A prospective, open label post market registry to collect Patient Reported Outcomes in an online data capture registry, maintained by Pelvalon, of women with fecal incontinence exiting the LIBERATE study (NCT02428595) continuing…
- Conditions
- Fecal Incontinence, Bowel Dysfunction, Bowel Incontinence, Accidental Bowel Leakage
- Trial name
- LIBERATEPRO (NCT03028636)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Pelvalon, Inc.
Irritable Bowel Syndrome
Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of JNJ-27018966 (eluxadoline) compared with placebo in the treatment of patients with irritable bowel syndrome with diarrhea…
- Trial name
- NCT01130272
- Testing
- Eluxadoline
- Where
- 288 sites in United States
- Volunteers
- 807 people
- Sponsor
- Furiex Pharmaceuticals, Inc
Proctitis, Proctosigmoiditis
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who…
- Trial name
- NCT01008410
- Testing
- Budesonide
- Where
- 63 sites in United States
- Volunteers
- 265 people
- Sponsor
- Bausch Health Americas, Inc.