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NCT ID: NCT00315003 Terminated - Clinical trials for Otitis Media, Suppurative

TELI COM - Telithromycin in Children With Otitis Media

Start date: January 2006
Phase: Phase 3
Study type: Interventional

This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and <72 months [< 6 years of age]) with AOM.Subjects will be randomized to receive either telithromycin (50 mg/mL) oral suspension 25 mg/kgonce daily for 5 days or azithromycin (40 mg/mL) oral suspension (10 mg/kg once on Day 1, followed by 5 mg/kg once daily on Days 2-5, not to exceed 500 mg onDay 1 and 250 mg/day from Days 2 - 5. Matching placebo suspensions for telithromycin and azithromycin will also be dispensed to provide blinding for the different treatment regimens.Assessments and reporting of safety will be carried out at all visits.

NCT ID: NCT00314938 Terminated - Clinical trials for Growth Hormone Deficiency

A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency

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

This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. In addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using PK/PD modeling

NCT ID: NCT00313417 Terminated - Clinical trials for Major Depressive Disorder

Creatine as a New Therapeutic Strategy in Depression

Start date: January 2007
Phase: Phase 4
Study type: Interventional

Creatine as a new therapeutic strategy in depression: A double-blind, parallel, randomized, add-on clinical trial of creatine versus placebo added to antidepressant treatment of patients with major depressive episode.

NCT ID: NCT00312793 Terminated - Knee Injuries Clinical Trials

The Efficacy and Safety of Electronic Stimulation in Patients Who Underwent Reconstruction of the Anterior Cruciate Ligament

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to evaluate the efficacy and safety of Myospare, a non-invasive device, which is connected to the body via electrodes placed in the injured leg. The electrodes which are placed in the middle or upper thigh will stimulate the quadriceps muscle. Myospare will be installed 1 day after the anterior cruciate ligament (ACL) reconstruction surgery and will be removed after 6 weeks of treatment. The patients will be assigned to two groups: 1. Physiotherapy plus Myospare 2. Only physiotherapy The hypothesis of the study is that electrical stimulation combined with voluntary exercise is more effective than voluntary exercise alone.

NCT ID: NCT00310388 Terminated - Epilepsy Clinical Trials

Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial. 115097

Start date: July 5, 2006
Phase: Phase 3
Study type: Interventional

This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until the subject withdraws from the study or until the program is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia, and South Africa. The primary objective of the study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the double-blind Study VRX-RET-E22-302. Secondary objectives are: to evaluate efficacy of long-term treatment with retigabine and patient quality of life and to evaluate whether retinal pigmentation, unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of nails, lips, skin or mucosa change over time after discontinuation of retigabine.

NCT ID: NCT00307918 Terminated - Clinical trials for Elevated Intraocular Pressure

Acupuncture for Elevated Intraocular Pressure

Start date: May 2006
Phase: Phase 3
Study type: Interventional

Glaucoma is the leading cause of irreversible blindness in the world, resulting from progressive axonal destruction of the optic nerve. Primary open-angle glaucoma is the most common form, and it is usually painless with insidious onset. Conventional treatment is focused on lowering intraocular pressure (IOP), the one risk factor that can be modified, which has been demonstrated to protect against further damage to the optic-nerve head. Acupuncture is an ancient treatment which has been found to be beneficial for many ailments, and may reduce IOP. We propose a pilot study to evaluate whether acupuncture is an effective and safe modality for reducing elevated IOP in patients with open angle glaucoma and primary ocular hypertension. Patients with elevated IOP on tonometric measurement (20mmHg < IOP < 30mmHg) will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment. Treatment will last for four-weeks (for a total of 8 treatments), and patients will be evaluated for IOP diurnal curves at 2 weeks (4 treatment), 4 weeks (end of treatment ) and then 4 weeks following the last treatment.

NCT ID: NCT00307853 Terminated - Clinical trials for Total Knee and Total Hip Arthroplasty

TRAUMEEL for Pain After Total Knee/Hip Arthroplasty

Start date: August 2008
Phase: Phase 3
Study type: Interventional

We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption following Total Knee or Hip Arthroplasty. 224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. Patients will be randomized to receive either intraoperative injection and post operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable oral placebo tablets. Baseline measurements of relevant outcome measures will taken preoperatively. In the recovery room, the patient will begin to receive IV Dipyrone (Optalgin) 1000mg, for a total of 4 doses during the first 24 hours postoperatively (1000 mg every 6 hours). Once back in the ward, the patient will be connected to an IV Patient-Controlled Analgesia (PCA) device, enabling the self-administration of morphine at a set dose of 1mg every 8 minutes, should the patient require it. The PCA memory registers the time and dose, and the data will be used later to evaluate post-operative pain.

NCT ID: NCT00300196 Terminated - Stroke Clinical Trials

ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke

Start date: March 2006
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to determine whether a brief intravenous infusion of ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.

NCT ID: NCT00297232 Terminated - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Natalizumab (Tysabri) Re-Initiation of Dosing

STRATA
Start date: March 2006
Phase: Phase 3
Study type: Interventional

The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS) therapies to natalizumab. The primary objective for the long-term treatment period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by Expanded Disability Status Scale (EDSS) changes over time.

NCT ID: NCT00295165 Terminated - Crohn Disease Clinical Trials

Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

Start date: January 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.