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NCT ID: NCT00206674 Completed - Crohn Disease Clinical Trials

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

Start date: September 2004
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.

NCT ID: NCT00206219 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)

Start date: November 2003
Phase: Phase 3
Study type: Interventional

This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer in terms of overall survival.

NCT ID: NCT00205777 Completed - Osteoporosis Clinical Trials

Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

Start date: December 2001
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.

NCT ID: NCT00196989 Completed - Clinical trials for Diabetes Mellitus, Type 2

Study In People With Type 2 Diabetes

Start date: September 2005
Phase: Phase 2
Study type: Interventional

This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects with T2DM (Type 2 Diabetes Mellitus).

NCT ID: NCT00196742 Recruiting - Fabry Disease Clinical Trials

Fabry Disease Registry & Pregnancy Sub-registry

Start date: July 31, 2001
Phase:
Study type: Observational [Patient Registry]

The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The primary objectives of the Registry are: - To enhance the understanding of the variability, progression, and natural history of Fabry disease, including heterozygous females with the disease; - To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care; - To characterize and describe the Fabry population as a whole; - To evaluate the long-term safety and effectiveness of Fabrazyme® Fabry Pregnancy Sub-registry: This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Fabry Registry, regardless of whether she is receiving disease-specific therapy (such as enzyme replacement therapy with agalsidase beta) and irrespective of the commercial product with which she may be treated. Data from the Sub-registry are also used to fulfill various global regulatory requirements, to support product development/reimbursement, and for other research and non-research-related purposes. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.

NCT ID: NCT00195559 Completed - Clinical trials for Premenstrual Syndrome

Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder

Start date: September 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.

NCT ID: NCT00195351 Completed - Appendicitis Clinical Trials

Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection

Start date: September 2005
Phase: Phase 4
Study type: Interventional

This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score < 10 and > 10. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).

NCT ID: NCT00192647 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Induction Dosing With Peginterferon Alfa-2a (40KD) and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1

Start date: September 2004
Phase: Phase 4
Study type: Interventional

This study will evaluate the addition of a higher-dose induction treatment period with peginterferon alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with Pegasys and ribavirin, compared to standard-dose treatment without induction dosing, in treatment-naive participants with CHC, genotype 1. The anticipated time on study treatment is 48 weeks, and the target sample size is 500 or more individuals.

NCT ID: NCT00192478 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524

Start date: February 2004
Phase: Phase 1/Phase 2
Study type: Interventional

MEDI-524 given for up to 5 doses at 3 and 15 mg/kg to high-risk children appeared to be safe and well tolerated.

NCT ID: NCT00191620 Completed - Clinical trials for Non-Small-Cell Lung Carcinoma

Study Comparing Short Infusion Vs. Fixed Dose of Cisplatin + Gemcitabine in Non Small Cell Lung Cancer.

Start date: March 2004
Phase: Phase 2
Study type: Interventional

The purposes of this study are to determine: How standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus cisplatin in the treatment of non-small cell lung cancer. The safety of standard gemcitabine plus cisplatin and any side effects that might be associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.