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A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Patients

The purpose of this current study is to evaluate the efficacy and safety of the 3-day oral aprepitant regimen when administered concomitantly with ondansetron, with or without dexamethasone, in pediatric patients, from 6 months to 17 years of age,…

A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers

The primary aim of the study is to determine the effect of orally administered AZD2516 as a reduction of the number of reflux episodes, in comparison with placebo, over a period of approximately three hours after a meal, in healthy male volunteers.

A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.

To assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.

Combined intracutaneous and intraperitoneal anaesthesia for postoperative pain reduction after laparoscopic cholecystectomy

To analyse the effect of preoperative intracutaneous and intraperitoneal instillation of levobupivacaine on postoperative pain after laparoscopic cholecystectomy

Effect of the consumption of a fermented dairy product on constipation in children: a multi-centre randomized controlled trial.

To determine the clinical effect and tolerance of BA in children with functional constipation aged 3-16 years.

A Double-Blind, Placebo-Controlled, Randomized, Multiple Ascending Oral Dose Study to Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of JNJ-26070109 In Healthy Subjects

JNJ-2607019 is an investigational drug being developed for gastroesophageal reflux disease (GERD) to reduce the complaints of abdominal pain and heartburn in people with this disease. JNJ-26070109 inhibits the gastrin receptor in the stomach. The…

A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Male Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of JNJ-26070109

JNJ-2607019 is an investigational drug being developed for gastroesophageal reflux disease (GERD) to reduce the complaints of abdominal pain and heartburn in people with this disease. JNJ-26070109 inhibits the gastrin receptor in the stomach. The…

A phase III, randomized, placebo-controlled clinical trial to study the efficacy and safety of MK-0517/fosaprepitant and ondansetron versus ondansetron for the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric subjects receiving emetogenic chemotherapy

The objective of the study is to evaluate the efficacy and safety of a single dose of fosaprepitant when administered concomitantly with ondansetron, with or without dexamethasone, in subjects birth to 17 years of age receiving emetogenic…

A MULTICENTRE, SAD, AND MAD CLINICAL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF IV TREATMENT OF CALY-002 IN HEALTHY SUBJECTS AND SUBJECTS WITH COELIAC DISEASE AND EOSINOPHILIC OESOPHAGITIS

The objectives of Part B of the study are as follows: Primary: To assess the safety and tolerability of CALY-002 following multiple ascending doses administered IV in subjects with coeliac disease (CeD). Secondary: (1) To characterise the PK of CALY…

Carbohydrate induced resilience of the gut microbiome after antibiotics use

The objective of this study is to investigate the potential of a dietary fiber, 2'-fucosyllactose (2'-FL), to improve gut microbiome resilience after antibiotics use.Furthermore it will also be investigated whether there is a link between…

Multicenter, semi-blinded, randomized, controlled, parallel arms clinical study on the performance of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody, for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer.

The primary objective of this clinical trial is to assess the performance of SGM-101 in theintraoperative detection of resection margins and metastases in patients undergoing curativesurgery for colorectal cancer. SGM-101 will be administered as a…

A double-blind, randomized, placebo-controlled, phase 2a study to evaluate the safety, tolerability, and pharmacodynamic (PD) effects of two infusions of escalating doses of TPM502 in adults diagnosed with celiac disease (CeD)

Main objective:To evaluate the safety and tolerability of two i.v. infusions of escalating doses of TPM502 in CeD patients.Secondary objectives:• To identify PD effects consistent with the induction of antigen-specific immune tolerance following the…

The effect of galacto-oligosaccharides on gut complaints without medical diagnosis (e.g. bloating, constipation, diarrhea) in adult women

to assess the effect of 21 days of consumption of 5.5 g GOS powder on the gut comfort component score (based on 5 questions), as compared to a control group receiving maltodextrin (control product).

Modulation of small intestinal microbial composition and activity, systemic immune adaptation and blood transcriptional changes induced by 2-wks consumption with 2 fermented milk products; a randomized, exploratory, cross-over, double blind, controlled study in ileostomy patients

Rationale: to determine the small intestinal microbiota response in humans to dietary interventions for two consecutive weeks, and to relate this to parameters of intestinal barrier function and immune and metabolic responses in blood, as functional…