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NCT ID: NCT01265979 Completed - Clinical trials for Gastrointestinal Stromal Tumors

WB-DWI for Early Prediction of Therapy Response in Patients With Advanced Metastatic GIST Treated With Regorafenib

Start date: January 2011
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate WB DWI as early predictor of response to treatment with regorafenib or placebo in patients with advanced metastatic GIST.

NCT ID: NCT01265719 Completed - Glaucoma Clinical Trials

Long-Term Non-Interventional Latanoprost Study

LYNX
Start date: December 2010
Phase:
Study type: Observational

This is a non-interventional, prospective, longitudinal cohort study. A total of 150 pediatric subjects with glaucoma or elevated intraocular pressure, including 75 latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects, will be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a non-interventional study, the study subjects' continued use of latanoprost and assessments of ocular events will be obtained through the routine medical follow-up with treating ophthalmologists or other designated members of the medical care team.

NCT ID: NCT01265238 Completed - Stroke Clinical Trials

Neuro-orthopaedic Surgery in the Treatment of the Spastic Equinovarus Foot

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

Spastic equinovarus foot (SEF) is a major cause of disability in stroke patients. Treatments may include physical therapy, orthosis, botulinum toxin (BTX) injections, selective tibial neurotomy and tendon lengthening and/or transfer. Until now, no study has been conducted to assess the result of neuro-orthopaedic surgery in the treatment of SEF. The aim of this study is to evaluate the benefit of neuro-orthopaedic surgery (selective neurotomy and/or Achilles tendon lengthening and/or tibialis anterior transfer) in case of SEF according to the 3 domains of the International Classification of Functioning, Disability and Health (ICF)of the World Health organisation (WHO)

NCT ID: NCT01263015 Completed - Clinical trials for Infection, Human Immunodeficiency Virus I

A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)

Start date: February 1, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.

NCT ID: NCT01262898 Completed - Gastroparesis Clinical Trials

Dose Response of 28 Days of Dosing of GSK962040 in Type I and II Diabetic Male and Female Subjects With Gastroparesis

Start date: May 3, 2011
Phase: Phase 2
Study type: Interventional

GSK962040 is a novel small molecule motilin agonist. The Phase I studies (MOT107043 and MOT109681) demonstrated that single doses of GSK962040 up to 150 mg and repeat dosing of up to 125 mg/day for 14 days were well tolerated with adverse events not occurring in greater prevalence than placebo, and no significant abnormal vital sign, ECG, or clinical laboratory findings. Pharmacokinetic parameters were linear and approximately dose proportional over the range of doses administered. Single doses of 50 mg - 150 mg GSK962040 significantly increased the rate of gastric emptying up to 40% as measured by the 13C octanoic acid stable isotope breath test. A similar effect of 50 mg and 125 mg on gastric emptying was observed throughout repeated dosing to healthy volunteers for 14-days. The aims of the present investigation (MOT114479) are to assess the pharmacodynamic effects (gastric emptying and symptoms), safety, tolerability, and pharmacokinetics of GSK962040 after 28 days of once-daily dosing in Type I and Type II diabetic subjects with gastroparesis. An additional aim is to characterize the dose/exposure - pharmacodynamic effect relationship.

NCT ID: NCT01262651 Completed - Pain Clinical Trials

Sativex® for Relieving Persistent Pain in Participants With Advanced Cancer

Start date: November 25, 2010
Phase: Phase 3
Study type: Interventional

This 9-week study aimed to determine the efficacy, safety and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer. Eligible participants were not required to stop any of their current treatments or medications.

NCT ID: NCT01262391 Completed - Clinical trials for Urinary Bladder, Overactive

Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents

Start date: October 20, 2010
Phase: Phase 1
Study type: Interventional

This single-dose study will investigate how well solifenacin suspension is taken up, how long it stays in the body and how well it will be tolerated in children and adolescents aged 5-17 years with symptoms of overactive bladder.

NCT ID: NCT01262365 Completed - Clinical trials for Systemic Lupus Erythematosus

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

EMBODY1
Start date: December 2010
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)

NCT ID: NCT01261611 Completed - Cervical Dystonia Clinical Trials

Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia

Start date: April 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an approved drug called Dysport.

NCT ID: NCT01261325 Completed - Epilepsy Clinical Trials

Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures

BRITE
Start date: December 2010
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.