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NCT ID: NCT01700140 Completed - Clinical trials for Radiotherapy-induced Nausea and Vomiting (RINV)

Phase II Study of SyB D-0701 for Radiotherapy-Induced Nausea and Vomiting (RINV)

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

The purpose of this study is to explore the dose response of SyB D-0701 for preventing nausea and emesis associated with radiotherapy (fractionated/localized irradiation) in cancer patients scheduled to receive radiotherapy (fractionated/localized irradiation) alone.

NCT ID: NCT01699724 Completed - Healthy Clinical Trials

Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects

Start date: September 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition with water in Healthy Japanese Subjects

NCT ID: NCT01699698 Completed - Clinical trials for Pancreatic Adenocarcinoma

Pancreatic Juice Diagnosis From Duodenum

Start date: October 2012
Phase: N/A
Study type: Interventional

Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis to screen UICC stage II pancreatic ductal adenocarcinoma patients.

NCT ID: NCT01698918 Completed - Clinical trials for Hormone Receptor Positive Breast Cancer

Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer

BOLERO-4
Start date: March 7, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. Moreover, the study also aimed to investigate the efficacy and safety of second line treatment with everolumus plus examestane in participants whose disease progressed during everolimus plus letrozole therapy.

NCT ID: NCT01698905 Active, not recruiting - Clinical trials for Chronic Myeloid Leukemia

Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)

ENESTop
Start date: December 20, 2012
Phase: Phase 2
Study type: Interventional

A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at least 3 years and have very small amount of leukemia cells remaining after the nilotinib (Tasigna) treatment will qualify for the study.

NCT ID: NCT01698801 Completed - Multiple Myeloma Clinical Trials

A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma

Start date: October 1, 2012
Phase: Phase 2
Study type: Interventional

To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.

NCT ID: NCT01697605 Completed - Clinical trials for Tumor With Alterations of the FGF-R

A Phase I Study of Oral BGJ398 in Asian Patients

Start date: October 19, 2012
Phase: Phase 1
Study type: Interventional

This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).

NCT ID: NCT01697267 Completed - Clinical trials for Microscopic Polyangiitis

Rituximab Vasculitis Maintenance Study

RITAZAREM
Start date: April 2013
Phase: Phase 3
Study type: Interventional

Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody (ANCA) vasculitis following major European and US trials reported in 2010. After a time, its effect wears off and the disease can return. This occurs in at least half of patients within 2 years of receiving Rituximab. A preliminary study in Cambridge has suggested that repeating rituximab every six months stops the disease returning and is safe. The RITAZAREM trial will find out whether repeating rituximab stops vasculitis returning and whether it works better than the older treatments, azathioprine or methotrexate. It will also tell us how long patients remain well after the repeated rituximab treatments are stopped, and if repeated rituximab is safe. We should also learn useful information about the effects of rituximab on quality of life and economic measures. The trial results will help decide the best treatment for future patients who have their vasculitis initially treated with rituximab. RITAZAREM aims to recruit patients with established ANCA vasculitis whose disease has come back 'relapsing vasculitis'. All patients will be treated with rituximab and steroids and we anticipate that most will respond well. If their disease is under reasonable control after four months, further treatment with either rituximab (a single dose ever four months for two years) or azathioprine tablets will be chosen randomly. The patients in the rituximab and azathioprine groups will then be compared. Patients will be in the trial for four years. The study has been designed by members of the European Vasculitis Study group (EUVAS) and the Vasculitis Clinical Research Consortium (VCRC). It will include 190 participants from 30 hospitals in Europe, the USA, Australia and Mexico. RITAZAREM is being funded by Arthritis Research UK, the U.S. National Institutes of Health and by Roche/Genentech.

NCT ID: NCT01697111 Completed - Endometriosis Clinical Trials

Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis

Start date: October 2012
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study (24-week treatment-comparison phase) with an open-label reference arm of active comparator (dienogest) followed by 28-week long-term treatment phase. The primary objective of this study is to confirm the superiority of BAY86-5300 when administered with an extended flexible regimen for the treatment of endometriosis-associated pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks. The secondary objective is to investigate the long-term safety of BAY86-5300 in patients treated with an extended flexible regimen for one year, and the bleeding pattern of BAY86-5300 when administered with an extended flexible regimen compared to dienogest.

NCT ID: NCT01696500 Completed - Clinical trials for Stevens-Johnson Syndrome

Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.

Start date: October 2012
Phase: Phase 3
Study type: Interventional

Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, efficacy of NPB-01 for therapy of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis will be evaluated the disease evaluation score et al. As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by 20 days after the start of the study treatment.