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NCT ID: NCT01545050 Terminated - Crohn's Disease Clinical Trials

Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease

Start date: June 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy.

NCT ID: NCT01536418 Terminated - Crohn's Disease Clinical Trials

An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease

SHIELD-4
Start date: November 11, 2011
Phase: Phase 3
Study type: Interventional

This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index [CDAI] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.

NCT ID: NCT01535196 Terminated - Clinical trials for Chronic Heart Failure

Vitamine D Treatment in Chronic Heart Failure

Start date: December 2012
Phase: Phase 3
Study type: Interventional

The investigators hypothesized that in vitamin D deficiency the 25-OH-D3 vitamin substitution improve the heart function in chronic heart failure. Type of study: Controlled, randomized, double blind, placebo control Number of patient: 300; 150 treated and 150 placebo controlled Type of drug: 180 000 IU 25-OH-D3 vitamin oil (Vigantol) per month in the 0,1,2,3,6, month Duration of study:1+1 year Primary end points: Survival rate, Ejection fraction by ultrasound, Brain natriuretic peptid, Secondary end points: Safety of D-vitamin supplementation, well being score, blood pressure, BMI Walking distant in 6 minutes Visits: Screening, Randomization, 1month, 2 month, 3 month, 6 month, 12 month, 24 month,

NCT ID: NCT01529034 Terminated - Epilepsy Clinical Trials

Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters

Start date: July 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

NCT ID: NCT01518959 Terminated - Clinical trials for Chronic Lymphoid Leukemia

The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases

D-HEM
Start date: January 2012
Phase: Phase 3
Study type: Interventional

Recent data have shown that the inadequate vitamin D status plays a role in the manifestation of the haematologic tumors and serum vitamin D level has a prognostic role also as it determines the tumor mortality. But data have not proved a causal relationship between the inadequate vitamin D status and the unfavourable outcomes so far. It is also still unknown, whether the normalization of vitamin D status in patient with vitamin D inadequacy is able to improve the prognosis and survival. In this study the investigators examine the role of the adequate vitamin D substitution in the improvement of the outcomes of haematologic disorders.

NCT ID: NCT01499667 Terminated - Clinical trials for Relapsing Remitting Multiple Sclerosis (RRMS)

Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod

TOFIINGO
Start date: September 2011
Phase: Phase 3
Study type: Interventional

This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.

NCT ID: NCT01499355 Terminated - Lupus Nephritis Clinical Trials

BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis

ATLAS
Start date: July 2012
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven Lupus Nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population. Participants who complete this study through Week 52 will be offered the option to enter an Extension study under a separate protocol 211LE202 (NCT0193089).

NCT ID: NCT01491854 Terminated - Clinical trials for Short Children Born Small for Gestational Age (SGA)

Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age

SGA
Start date: July 20, 2009
Phase: N/A
Study type: Interventional

This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).

NCT ID: NCT01489046 Terminated - HIV-1 Infection Clinical Trials

Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive

Start date: February 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects

NCT ID: NCT01485094 Terminated - Neuralgia Clinical Trials

A Study to Assess the Safety and Efficacy of 7 Days Treatment With a Novel Analgesic in Subjects With Peripheral Neuropathic Pain

Start date: February 2012
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to determine whether a novel analgesic is effective in treating of neuropathic pain caused by herpetic infection, surgery, or trauma.