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A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)

The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.The secondary objective is to evaluate changes in patients* quality of life (QOL) through week 84.

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease

The primary objective of this study is to evaluate the long-term efficacy, safety, and tolerability of repeated administration of adalimumab in subjects with Crohn's disease (CD) who participated in and successfully completed Study M14-115.The…

A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases

Primary: The primary objective of the Double-blind Acute Phase of the study is to assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate UC.The primary…

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn's Disease

Study Objectives:Primary Objective* To determine the safety profile of long-term MLN0002 treatmentResource Utilization and Patient-Reported Outcome Objectives* To determine the effect of long-term MLN0002 treatment on time to major inflammatory…

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn*s Disease (CCX114644)

Primary: Safety and tolerability. Secondary: Effectiveness, quality of life, healthcare resource utilisation, work productivity.

Effect of Prucalopride on Gastroesophageal Reflux, Esophageal Motility and Gastric Emptying in healthy volunteers

To asses the effect of Prucalopride on esophageal contraction characteristics and lower esophageal sphincter pressure, gastric emptying and esophageal reflux parameters in healthy male subjects

A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis

The primary objective of this Phase 3 extension study will be to obtain essential long term safety data to augment the overall safety database. The secondary objective will be to augment the efficacy information collected in the double-blind study (…

Safety and Effectiveness using DEXmedetomidine sedation versus Propofol/Alfentanil sedation
during oesophagus interventions.
(SEDEX)

The aim of this study is to determine the patients* and endoscopists experiences and patients* safety with different sedation protocols.

A Multicentre, Long-term Safety, Efficacy and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged *6 to <18 years with Functional Constipation

To assess the long-term safety, efficacy, and pharmacokinetics of oral lubiprostone 12 or 24 mcg capsules dosed twice daily (BID) when administered orally for 36 weeks in paediatric subjects with functional constipation. Evaluation of lubiprostone…

A Randomised, Double-blind, Active Treatment Study to Induce
Clinical Response and/or Remission with GSK1605786A in
Subjects with Moderately-to-Severely Active Crohn*s Disease

Primary Objective:To induce clinical response (CDAI decrease from baseline * 100 points) and/or remission(CDAI &lt;150) following 12 weeks of treatment with one of two active doses ofGSK1605786A for qualification of subjects for enrolment into a…

HYPerbaric OXygen therapy for benign anastomotIC esophageal strictures: a pilot study

The overall objective of this pilot study is to evaluate the effect of HBOT on recurrent and refractory esophageal anastomotic strictures.

Diagnostic value of novel MR imaging techniques for the primary staging and restaging of rectal cancer

The primary objectives are to determine the diagnostic performance of gadofosveset-enhanced T1-weighted MR imaging for the discrimination between pN0 and pN+ patients for both primary staging and restaging after chemoradiotherapy and to determine…

A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn*s Disease

The purpose of this study is to evaluate the safety and effectiveness of adalimumab for the treatment of moderate to severe Crohn*s disease in children between 6-17 years of age. In addition, information will be collected to select the most…

Non-randomised,open, multi-center trial evaluating feasibility and safety of Tachosil application on a colorectal anastomosis

The primary efficacy variable is if the TachoSil application was feasible. A feasible application implies that the entire TachoSil adhere, TachoSil covers at least 1 cm beyond the margins of the anastomosis line and if more TachoSil sponges are used…

A MULTICENTER, OPEN-LABEL PHARMACOKINETIC, PHARMACODYNAMIC, CLINICAL SYMPTOMS, AND SAFETY STUDY OF PANTOPRAZOLE DELAYED-RELEASED GRANULES ADMINISTERED AS A SUSPENSION IN NEONATES AND PRETERM INFANTS WITH A CLINICAL DIAGNOSIS OF GASTROESOPHAGEAL REFLUX DISEASE

Primary: To determine whether or not consistent exposures can be achieved in neonates and preterm infants with presumed GERD receiving oral doses of pantoprazole. Secondary: PK and PD assessment after single dose and steady state. Determination fo…

A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.

Investigating the safety of adalimumab when administered in subjects with Crohn*s Disease as well as evaulating the efficacy of adalimumab for the induction and maintenance of clinical remission and fistula closure in subjects with moderate to…

A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis

To evaluate the long term maintenance of response, safety and tolerability of repeatedadministration of adalimumab in subjects with Ulcerative Colitis who participated in and successfullycompleted Protocol M06-826 or Protocol M06-827.The secondary…

A Multicenter, Single arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients with Metastatic Colorectal Cancer (mCRC) Previously Treated with an Oxaliplatin-Containing Regimen

Primary: To provide metastatic colorectal cancer patients with access to aflibercept and todocument the overall safety in these patientsSecondary: To document the Health-Related Quality of Life of aflibercept in this patientpopulation

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Primary Objective• To assess the safety and tolerability of long-term tofacitinib therapy in subjects with UC.Secondary Objectives• To evaluate the efficacy of long term tofacitinib therapy in subjects with UC.• To evaluate the effect of long term…

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH
MODERATELY TO SEVERELY ACTIVE CROHN*S DISEASE PREVIOUSLY ENROLLED
IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

The objectives of this open-label extension*safety monitoring (OLE-SM) study are as follows: Part 1 (Open-Label Extension; OLE) • To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE) Part 2 (Safety…