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NCT ID: NCT00551707 Completed - Clinical trials for Rheumatoid Arthritis

Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis

MARS-1
Start date: October 2007
Phase: Phase 2
Study type: Interventional

CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand Osteoarthritis (OA) and Rheumatoid Arthritis (RA). In this trial, CRx-102 will be given to subjects with active RA as an add-on therapy to existing stable doses of Disease Modifying Anti-Rheumatic Drugs (DMARDs) including methotrexate (MTX), sulfasalazine, hydroxychloroquine, leflunomide or azathioprine. MTX in combination with other DMARDs (e.g., sulfasalazine or hydroxychloroquine) will be permitted to reflect the current standard of care practices within rheumatology.

NCT ID: NCT00550238 Completed - Clinical trials for Parkinson's Disease Psychosis

A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

Start date: July 2007
Phase: Phase 3
Study type: Interventional

To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.

NCT ID: NCT00549939 Completed - Clinical trials for Neurogenic Urinary Bladder

Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction

ALFACHIN
Start date: October 2007
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the efficacy of Alfuzosin in comparison to Placebo on the detrusor Leak Point Pressure (LPP) in children and adolescents 2-16 years of age with elevated detrusor LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O. Secondary objectives were: - To investigate the safety and tolerability of two doses of Alfuzosin in comparison to Placebo in children and adolescents, - To evaluate the effects of the two doses of Alfuzosin in comparison to Placebo on: - Detrusor compliance, - Urinary tract infection, - To investigate the pharmacokinetics of Alfuzosin (population kinetics), - To evaluate the 12-month long-term safety of Alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day. The study consisted of 2 periods: - a 12-week double blind treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day or placebo then, - a 40-week open label extension treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day.

NCT ID: NCT00548405 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two

CARE-MS II
Start date: October 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.

NCT ID: NCT00546351 Completed - Clinical trials for Painful Diabetic Neuropathy

Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.

Start date: May 2004
Phase: Phase 3
Study type: Interventional

SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.

NCT ID: NCT00545779 Completed - Clinical trials for Post-Menopausal Osteoporosis

BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.

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

This single arm study will assess patient preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Patients currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify patients who may benefit from a monthly Bonviva regimen. Eligible patients will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg po. At the beginning and end of Bonviva treatment, all patients will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

NCT ID: NCT00542815 Completed - Clinical trials for Chronic Kidney Disease

A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

Start date: November 2007
Phase: Phase 3
Study type: Interventional

This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

NCT ID: NCT00542386 Completed - Clinical trials for Chronic Kidney Disease

A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

Start date: December 2007
Phase: Phase 3
Study type: Interventional

This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.

NCT ID: NCT00533793 Completed - Trauma Clinical Trials

Adjunctive Therapy to Treat Tibial Shaft Fractures

TSF
Start date: April 2007
Phase: Phase 2
Study type: Interventional

A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or 1.0 mg/mL I-040202.

NCT ID: NCT00532532 Terminated - Muscle Spasticity Clinical Trials

Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis

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

A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity associated with multiple sclerosis. This study has three purposes: 1. To determine whether AV650 is safe for patients with multiple sclerosis; 2. To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with multiple sclerosis; and, 3. To assess what the body does with AV650 once it is ingested (Germany and Czech Republic sites only).