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NCT ID: NCT00545909 Completed - Clinical trials for Postmenopausal Osteoporosis

BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis

Start date: March 2006
Phase: Phase 4
Study type: Interventional

This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

NCT ID: NCT00537459 Completed - Clinical trials for Premature Ejaculation

A Study On Concentrations Of 16448 In Blood And The Safety Of This Compound In Healthy Males With Premature Ejaculation

Start date: December 2006
Phase: Phase 2
Study type: Interventional

16448 is being investigated for the treatment of primary premature ejaculation (PE) using a novel mode of action. There are no approved therapies for premature ejaculation, and novel therapies are needed for this syndrome. 16448 has been shown to increase ejaculatory latency in the PCA rat model of premature ejaculation. A novel instrument, the Sexual Assessment Monitor (SAM), will be used to measure ejaculatory latency time in this study. This device, which measures ELT under standard conditions, has been shown to provide a more reliable measure of ejaculatory latency compared to the use of a stopwatch during sexual intercourse

NCT ID: NCT00535691 Completed - Dermatitis, Atopic Clinical Trials

Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis

Start date: April 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to estimate the systemic exposure to tacrolimus in infants with atopic dermatitis after repeated application of tacrolimus ointment. Efficacy of tacrolimus ointment, evaluated by examination of treated areas, will also be measured.

NCT ID: NCT00534508 Completed - Dermatitis, Atopic Clinical Trials

Distribution of Tacrolimus in Skin, Atopic Dermatitis

Start date: December 2000
Phase: Phase 2
Study type: Interventional

This study was designed to further increase the understanding of the pharmacokinetics of tacrolimus in the affected skin of atopic dermatitis patients following repeated topical application of tacrolimus ointment 0.1%.

NCT ID: NCT00531362 Completed - Clinical trials for Cardiovascular Disease

Enteric Coating as a Factor in Aspirin Resistance

Start date: September 2007
Phase: N/A
Study type: Observational

Aspirin is an essential drug for the treatment of cardiovascular disease. The standard dose is 75mg per day (much lower than that for inflammation or fever). One of the side-effects of aspirin is a gastric ulcer which can be fatal. To prevent this it is common to use enteric-coated aspirin. This passes through the stomach intact and dissolves in the intestines. This prevents high levels of drug forming in the stomach reducing ulcer formation. Recently there is evidence of high levels of aspirin resistance, ie, patients who appear not to achieve the maximum benefit from aspirin. Clinical studies have shown a significant increase in mortality among these patients. A recent study that we performed showed that enteric-coated aspirin is not as effective as plain aspirin. This was especially noticeable in heavier volunteers. In fact it appeared that enteric-coated aspirin only delivers 50mg aspirin instead of the full 75 mg. For volunteers resistant to enteric-coated aspirin simply switching them to plain aspirin solved the problem. We propose to recruit patients on 75 mg enteric aspirin and test them for evidence of poor response to aspirin. Poor responders will then be given 75mg plain aspirin and tested for their response. Those that fail to respond will then receive 150 mg aspirin. If the results of the healthy volunteer study are replicated this would provide a very cheap and effective solution to a serious problem.

NCT ID: NCT00520741 Completed - Epilepsy Clinical Trials

Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures

ALEX-MT
Start date: August 2007
Phase: Phase 3
Study type: Interventional

The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

NCT ID: NCT00519961 Recruiting - Clinical trials for Peripheral Vascular Disease

A Prospective Study to Assess the Screening Value of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) for the Identification of Patients That Benefit From Additional Cardiac Testing Prior to Vascular Surgery

Start date: February 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to validate the screening potential of NT-proBNP for the identification of patients scheduled for vascular surgery who would benefit from additional pre-operative cardiac testing. All patients will have NT-proBNP concentrations measured pre-operatively. For low-intermediate risk patients only those with abnormal values will receive further cardiac testing; all high risk patients will be referred for additional testing.

NCT ID: NCT00518882 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes

LEAD-6
Start date: August 2007
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.

NCT ID: NCT00514683 Completed - Pulmonary Fibrosis Clinical Trials

Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis

Start date: August 2007
Phase: Phase 2
Study type: Interventional

The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis. The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC). As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy

NCT ID: NCT00514397 Recruiting - Clinical trials for Brain and Central Nervous System Tumors

Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma

Start date: January 2008
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating young patients with pontine glioma.