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NCT ID: NCT01309386 Completed - Neoplasms Clinical Trials

A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants

Start date: August 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the conversion rate based on the number of participants achieving pain control and safety within 1 week after switching the opioid (morphine-like medications) analgesics (drug used to control pain), when tapentadol extended-release (ER) (JNS024ER) is orally administered to participants treated with around-the-clock opioid analgesics, for their moderate to severe (very serious, life threatening) chronic (lasting a long time) malignant (cancerous) tumor-related (a mass in a specific area) cancer (abnormal tissue that grows and spreads in the body) pain.

NCT ID: NCT01308567 Completed - Prostate Cancer Clinical Trials

Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

FIRSTANA
Start date: May 5, 2011
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20 mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy. Secondary Objectives: - To evaluate safety in the 3 treatment arms. - To compare efficacy of cabazitaxel at 20 mg/m^2 and 25 mg/m^2 to docetaxel for: - Progression Free Survival (PFS) (RECIST 1.1) - Tumor progression free survival (RECIST 1.1) - Tumor response in participants with measurable disease (RECIST 1.1), - PSA response - PSA-Progression free survival (PSA-PFS). - Pain response in participants with stable pain at baseline - Pain progression free survival - Time to occurrence of any skeletal related events (SRE) - To compare Health-Related Quality of Life (HRQL). - To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

NCT ID: NCT01307267 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab

Start date: June 21, 2011
Phase: Phase 1
Study type: Interventional

A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive Non-Hodgkin's Lymphoma (NHL).

NCT ID: NCT01307072 Completed - Clinical trials for Proliferative Diabetic Retinopathy

Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome for Proliferative Diabetic Retinopathy

Start date: September 2008
Phase: N/A
Study type: Observational

The relationship between the surgical outcome of vitreous surgery for proliferative diabetic retinopathy and the compliance to ophthalmic follow-up examinations was evaluated.

NCT ID: NCT01306721 Completed - Rhinitis Seasonal Clinical Trials

Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis

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

Primary Objective: - To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg - pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg - pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60) in patients with seasonal allergic rhinitis (SAR). Secondary Objectives: - To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily activity impairment. - To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.

NCT ID: NCT01306487 Completed - Macular Holes Clinical Trials

Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery

Start date: March 2008
Phase: N/A
Study type: Observational

The objective is to determine whether a recovery of the microstructures of the foveal photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual acuity (BCVA) is determined.

NCT ID: NCT01305343 Completed - Clinical trials for Adult Spinal Deformity

Neurologic Complications in Spinal Deformity Surgery

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

240 subjects with "high risk" adult spinal deformity requiring surgical correction will be enrolled in a prospective multi-center international study. "High risk" patients are defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurologic complications in the form of new motor and sensory deficits will be monitored prospectively in all patients at hospital discharge, and at 6 weeks (± 2 weeks) six months (± 2 months) and 24 months(± 2 months) after the surgery. All new deficits will be adjudicated for relationship to the surgical intervention. Regression analyses will be used to evaluate the association between patient demographics, co morbidities, treatment history, spinal deformity characteristics, surgical characteristics, non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit after surgery.

NCT ID: NCT01305057 Completed - Dry Skin Clinical Trials

Efficacy Test on Skin Hydration and Skin Barrier Function

Start date: February 2009
Phase: N/A
Study type: Interventional

The effects of topically applied pyridoxine tri-isopalmitate (P-IP) which stimulates filaggrin synthesis in keratinocytes, on skin hydration and barrier function were examined. Subjects were separated into two groups to examine the effect of P-IP. Subjects were treated with P-IP formulation on one side of the face and with a placebo formulation on the other side twice daily (morning and evening) for 28 days. All subjects gave written informed consent prior to the study. The skin hydration and TEWL (transepidermal water loss) were evaluated by measuring skin surface conductance with a skin hygrometer SKICON 200EX (I.B.S. ltd., Japan) and TEWL meter AS-CT1 (ASAHI BIOMED, Tokyo, Japan), respectively.

NCT ID: NCT01303640 Completed - Clinical trials for Coronary Artery Disease

NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial

NEXT
Start date: May 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice.

NCT ID: NCT01303055 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effects of Alogliptin on Pancreatic Beta Cell Function

Start date: February 2011
Phase: N/A
Study type: Interventional

It is reported that pancreatic beta cell function is already declined at pre-diabetic stage, impaired glucose tolerance (IGT). It has not been clarified whether inhibitors of the dipeptidyl peptidase IV enzyme (DPP-IV inhibitors) improve beta cell function on human pancreas, however, if efficacy is ensured, they may become the first medicine to be chosen for treatments of type 2 diabetes and IGT. In this trial, a DPP-IV inhibitor, Alogliptin, or Metformin are given to diabetic patients whose HbA1c level is below 7.9%. Oral glucose tolerance test (OGTT) will be conducted before, a year after, and two years after the beginning of the trial and beta cell function will be evaluated.