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NCT ID: NCT01636817 Terminated - Clinical trials for Rheumatoid Arthritis

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics

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

This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa biologics and are on a stable background of methotrexate (MTX) therapy.

NCT ID: NCT01635166 Terminated - Clinical trials for Rheumatoid Arthritis

Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery

Start date: July 1, 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to monitor the performance of the DeltaMotion cup system in the treatment of patients with hip joint disease requiring a total hip replacement.Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

NCT ID: NCT01633710 Terminated - Clinical trials for Peripheral Arterial Disease

Multicentre Study to Investigate the Performance of the Padd Device in the Assessment of Peripheral Arterial Disease

Start date: May 2009
Phase: N/A
Study type: Observational

The study will compare Padd, a non-invasive automated optical device which uses a functional test to assess peripheral arterial disease (PAD), and Ankle brachial pressure index (ABPI) in the detection of PAD using as a gold standard, colour duplex ultrasound, in participants drawn from general practice, a hospital diabetic clinic and a tertiary vascular disease referral centre. The study hypothesis is that Padd performs at least as well as ABPI in detecting PAD.

NCT ID: NCT01633060 Terminated - Clinical trials for Metastatic Breast Cancer

A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

BELLE-3
Start date: October 3, 2012
Phase: Phase 3
Study type: Interventional

This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment. Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).

NCT ID: NCT01631942 Terminated - Healthy Clinical Trials

A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects

explorerâ„¢2
Start date: June 26, 2012
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.

NCT ID: NCT01627002 Terminated - Healthy Volunteers Clinical Trials

A Phase 1, First in Human Study to Investigate the Safety and Tolerability of PA401

Start date: May 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to examine the safety, tolerability, immunogenicity and the way the body absorbs, distributes, breaks down and excretes various increasing single and multiple subcutaneous doses of PA401 in healthy subjects. This study will also look at the effect of PA401 on inflammation in the lungs following an inhaled lipopolysaccharide (LPS) challenge (LPS is a bacterial cell wall fragment) and sputum induction (a procedure performed to help to cough up sputum (phlegm)) after a single subcutaneous dose of two dose levels.

NCT ID: NCT01626391 Terminated - Alzheimer's Disease Clinical Trials

Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's Disease

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

The primary purpose of this study is to assess the safety and tolerability of TRx0237 when taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or rivastigmine) and / or memantine to treat patients with mild to moderate Alzheimer's Disease.

NCT ID: NCT01622088 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Phase 3 Extension Study of Dexpramipexole in ALS

ENVISION
Start date: June 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

NCT ID: NCT01621828 Terminated - Anxiety Clinical Trials

Multimedia Information and Pre-operative Anxiety

MIPA
Start date: July 2012
Phase: N/A
Study type: Interventional

The aim of this study is to investigate a possible reduction in pre-operative anxiety in patients undergoing major elective surgery, by providing multimedia information regarding the patient pathway to and from the Operating Theatre.

NCT ID: NCT01617733 Terminated - Nelson Syndrome Clinical Trials

Pasireotide Therapy in Patients With Nelson's Syndrome

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

Nelson's syndrome, an expanding pituitary tumour, occurs in up to 30% of adults after bilateral adrenalectomy for Cushing's disease, for which no medical treatment exists. Plasma Adrenocorticotrophic hormone (ACTH) levels in these patients remain high, they are characteristically deeply pigmented, and may experience neurological effects as a consequence of the tumour. It is not known whether the tumour growth is due to the lack of cortisol feedback after adrenalectomy or whether the pituitary cells were preprogrammed to develop into a tumour. There is a real need for an effective medical management for Nelson's syndrome. This is especially true given the increasing data on the somewhat disappointing longterm outcome of transsphenoidal surgery, and the increasing use of aparoscopic bilateral adrenalectomy for failures of pituitary surgery or even as primary therapy for Cushing's disease. Therefore, it is likely that there will be increasing numbers of patients attending endocrine centres worldwide with Nelson's syndrome following bilateral adrenalectomy as part of their management for Cushing's disease. In view of this it is important to investigate all potential avenues for the treatment of Nelson's syndrome and translate any benefits to patients. This study, designed and initiated by the investigators, will assess if pasireotide reduces ACTH levels and tumour volume in patients with Nelson's syndrome. Patients will be recruited for a period of 32 weeks and receive 4 weeks of pasireotide twice daily and then 24 weeks of pasireotide long acting release therapy every 4 weeks. Over the 32 week protocol patients will make 12 visits for serial ACTH blood measurements and have 2 MRI scans to assess tumour volume.