Clinical trials: Functional Gastrointestinal Disorders
Cystic Fibrosis
A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)
The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).
- Trial name
- NCT05033080
- Testing
- VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA
- Where
- 139 sites in United States, Australia and 10 more
- Volunteers
- 435 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Rectal Cancer
Tecemotide (L-BLP25) in Rectal Cancer
The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25) administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects with newly diagnosed rectal cancer who are…
- Trial name
- SPRINT (NCT01507103)
- Testing
- Tecemotide (L-BLP25), cyclophosphamide (CPA), Chemoradiotherapy
- Where
- Netherlands
- Volunteers
- 124 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Ileus, Post-Operative Adhesions
A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel…
- Trial name
- PROFILE (NCT02836470)
- Testing
- LB1148
- Where
- 28 sites in United States
- Volunteers
- 112 people
- Sponsor
- Palisade Bio
Irritable Bowel Syndrome
EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth
Primary objective: to assess the efficacy of Bacillus clausii versus metronidazole in the eradication of the small intestinal bacterial overgrowth, 30 days after the end of treatment.
- Trial name
- NCT00331994
- Testing
- Bacillus clausii, Metronidazole
- Where
- Italy
- Volunteers
- 250 people
- Sponsor
- Sanofi
Irritable Bowel Syndrome, Constipation
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Constipation (IBS-C).
- Trial name
- RENEW-IBS-C (NCT07545772)
- Testing
- LY3537031
- Where
- 70 sites in United States, Belgium and 6 more
- Volunteers
- 342 people
- Sponsor
- Eli Lilly and Company
Irritable Bowel Syndrome
Effect of Probiotic Supplement on Bowel Function
The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.
- Trial name
- IBS2 (NCT01475929)
- Testing
- Probiotic supplement
- Where
- Finland
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Danisco
Cystic Fibrosis
Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR Function
This study is a multiple within participant crossover study to evaluate the effect of ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (CF) who have phenotypic or molecular evidence of…
- Trial name
- NCT01685801
- Testing
- Ivacaftor
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases), Irritable Bowel Syndrome With Constipation (IBS-C)
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.
- Trial name
- NCT03471728
- Testing
- linaclotide
- Where
- 47 sites in Japan
- Volunteers
- 2,475 people
- Sponsor
- Astellas Pharma Inc
Gastrointestinal Disorder, Functional, Regurgitation, Gastric
Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study
To compare the frequency of regurgitation and other digestive outcomes between infants who receive an infant formula based on whole goat milk and an infant formula based on cow milk proteins during the transition period from…
- Conditions
- Gastrointestinal Disorder, Functional, Regurgitation, Gastric, Colic, Infantile, Constipation - Functional
- Trial name
- TIGER (NCT05363553)
- Testing
- Infant formula based on whole goat milk, infant formula based on cow milk proteins
- Where
- Thailand
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Dairy Goat Co-operative (N.Z.) Limited
Irritable Bowel Syndrome
Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel…
- Trial name
- NCT01553591
- Testing
- Eluxadoline
- Where
- 283 sites in United States, Canada and 1 more
- Volunteers
- 1,282 people
- Sponsor
- Furiex Pharmaceuticals, Inc
Liver Disease
A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with normal hepatic function based on the…
- Trial name
- NCT01187186
- Testing
- ASP1941
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Chronic Hepatitis B Virus Infection, Chronic Hepatitis C Virus Infection
Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction
The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.
- Trial name
- PK (NCT01708889)
- Testing
- BMS-914143 (Peginterferon Lambda-1a)
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Cystic Fibrosis
SD Cystic Fibrosis Study
Subject with Cystic Fibrosis have increased clearance of many drugs. Based on pre-clinical data SB656933 was found to have low clearance and high bio-availability.
- Trial name
- NCT00605761
- Testing
- SB656933
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- GlaxoSmithKline
Liver Dysfunction
Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Moderate Impaired Hepatic Function
This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to moderate hepatic function impaired (Child-Pugh B，7-9) subjects in age…
- Trial name
- NCT02604498
- Testing
- Nemonoxacin
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Zhejiang Medicine Co., Ltd.
Irritable Bowel Syndrome
Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome.
- Trial name
- NCT00813098
- Testing
- LX1031 High Dose, LX1031 Low Dose
- Where
- 36 sites in United States
- Volunteers
- 155 people
- Sponsor
- Lexicon Pharmaceuticals
Infantile Colic, Infantile Functional Gastrointestinal Disorders
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants.
- Trial name
- NCT00655083
- Testing
- Nepadutant
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Menarini Group
Gastric Neoplasms, Pancreatic Neoplasms
Chromogranin A as Blood Marker in Cancer Patients
Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs) are a heterogenous group of neoplasms that arise from enterochromaffin cells of the gastrointestinal (GI) tract and pancreas. They account for 50-70% of all incident NETs.
- Conditions
- Gastric Neoplasms, Pancreatic Neoplasms, Small Intestinal Neoplasms, Colorectal Neoplasms
- Trial name
- NCT03817866
- Testing
- BRAHMS CgA II KRYPTOR
- Where
- 4 sites in United States, Germany
- Volunteers
- 175 people
- Sponsor
- Brahms AG
Urinary Incontinence, Urinary Incontinence, Urge
Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)
UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder/bowel musculature…
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge, Fecal Incontinence, Fecal Incontinence With Fecal Urgency
- Trial name
- NCT06091566
- Testing
- UCon-Bar
- Where
- 3 sites in Denmark
- Volunteers
- 20 people
- Sponsor
- InnoCon Medical
Advanced Cancer, Ovarian Cancer
COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies
Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM902 as monotherapy and in combination with COM701 in subjects with advanced…
- Conditions
- Advanced Cancer, Ovarian Cancer, Lung Cancer, Colon Cancer
- Trial name
- NCT04354246
- Testing
- Dose escalation: COM902 monotherapy., Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE), Cohort expansion: COM902 (RDFE) monotherapy.
- Where
- 9 sites in United States
- Volunteers
- 94 people
- Sponsor
- Compugen Ltd
Healthy, Hepatic Insufficiency
A Study of Canagliflozin in Study Participants With Various Degrees of Impaired Hepatic (Liver) Function
The purpose of the study is to determine the concentration of canagliflozin in blood and urine samples after the administration of canagliflozin to study participants with mild or moderate hepatic (liver) impairment compared with…
- Trial name
- NCT01186588
- Testing
- Canagliflozin
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.