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NCT ID: NCT00930644 Completed - Clinical trials for Short Bowel Syndrome

Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

Start date: September 21, 2009
Phase: Phase 3
Study type: Interventional

This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

NCT ID: NCT00930553 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

Start date: August 2009
Phase: Phase 3
Study type: Interventional

This open-label, rater-blinded extension study will enroll patients who have relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab [CAMMS223 (NCT00050778), CAMMS323 (NCT00530348) also known as CARE-MS I, or CAMMS324 (NCT00548405) also known as CARE-MS II]. The purposes of this study are: 1. To examine the long term safety and efficacy of alemtuzumab treatment in patients who received alemtuzumab as their study treatment in one of the prior studies. 2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for patients who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies. 3. To determine if and when further alemtuzumab treatment is needed, and the safety and efficacy of this "as needed" treatment. This applies both to patients who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.

NCT ID: NCT00930514 Completed - Clinical trials for Lymphoma, Follicular

A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma

Start date: September 2009
Phase: Phase 1
Study type: Interventional

This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and intravenous rituximab in participants with follicular lymphoma. In the first stage, participants who have achieved at least a partial response after induction treatment with intravenous rituximab will be randomized to one of 3 treatment cohorts, to receive rituximab 375 milligram per square meter (mg/m^2) intravenously, 375 mg/m^2 subcutaneously or 625 mg/m^2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of the subcutaneous dose (800 mg/m^2) which results in rituximab trough plasma concentration (C trough) values comparable to those achieved with the intravenous formulation, participants in the second stage of the study will be randomized to receive either the subcutaneous or intravenous formulation to demonstrate comparability of the C trough levels with both routes of administration. Maintenance therapy will continue every 2 or 3 months with the subcutaneous formulation.

NCT ID: NCT00930176 Completed - Factor X Deficiency Clinical Trials

A Study Investigating Treatment Factor X in People With Factor X Deficiency

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

The main objective of the study is to assess the pharmacokinetics of FACTOR X after a single dose of 25IU/kg. The secondary objectives of the study are to assess efficacy and safety of FACTOR X in the treatment of bleeding episodes over at least 6 months.

NCT ID: NCT00929929 Completed - Ageing Clinical Trials

Study to Assess the Effect of Leucine Along With Resistance Exercise on Muscle Strength and Quality of Life in Elders

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

The purpose of this study is to determine whether a nutritional supplement with an amino acid called leucine along with resistance exercise are effective in the improvement of muscle strength and quality of life in elderly people.

NCT ID: NCT00929877 Completed - Pain Clinical Trials

KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges

Start date: June 2009
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25 mg and 12.5 mg ketoprofen base) with placebo, on total pain relief summed over 15 to 120 min (TOTPAR15-120) after the first intake of study drug. Secondary Objectives: To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) with placebo after the first intake on: - the total pain relief summed over 15 to 360min (TOTPAR15-360) - the changes from baseline of global throat pain intensity assessed over 15 to 120min and over 15 to 360min. - the changes from baseline of throat soreness over 15 to 120min and over 15 to 360min - the changes from baseline of swollen throat over 15 to 120min and over 15 to 360min To compare pain relief, global throat pain intensity, throat soreness and swollen throat in the evening of days 1, 2 and 3 To evaluate the safety of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) and placebo at follow-up visit on: Day 4: - adverse events and clinical examination Day 7: - adverse events reporting (followed by a clinical examination if needed)

NCT ID: NCT00929240 Completed - Breast Cancer Clinical Trials

A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer

Start date: July 2009
Phase: Phase 3
Study type: Interventional

This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, and the target sample size is 100-500 individuals.

NCT ID: NCT00929188 Completed - Pain, Radiating Clinical Trials

A Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Cancer-related Pain

Start date: October 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the safety and effectiveness of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe cancer-related pain in terminally ill patients with a diagnosis of active cancer.

NCT ID: NCT00928681 Completed - Colitis, Ulcerative Clinical Trials

A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis

Start date: September 2005
Phase: Phase 1
Study type: Interventional

study to investigate the safety and efficacy properties of PF-00547659 in patients with active ulcerative colitis

NCT ID: NCT00927836 Completed - Clinical trials for Acute Ischemic Stroke

AXIS 2: AX200 for the Treatment of Ischemic Stroke

AXIS-2
Start date: May 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy of AX200 (filgrastim) in the treatment of acute ischemic stroke and to assess the safety and tolerability of AX200.