Clinical Trials Logo

Filter by:
NCT ID: NCT00735007 Completed - Multiple Sclerosis Clinical Trials

12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis.

Start date: July 2008
Phase: Phase 3
Study type: Interventional

The Electronic Device - The RebiSmart™ is an electronic injection device that is being studied for the delivery of Merck Serono's Rebif® New Formulation. The RebiSmart™ device is a stand-alone hand-held device with internal power supply. It is used for subcutaneous (under the skin) injections with single-use sterile disposable needles. The device will be kept in a storage box and placed in the refrigerator after each use. The key features of the RebiSmart™ are as follows: - Battery powered electromechanical automatic injector; - Automatic needle attachment and detachment; - Hidden needle before and after injection; - Injection can only be initiated by pressing the injection button when in contact with the skin; - Automatic needle insertion and injection of the preset dose into the subcutaneous (under the skin) tissue; - Adjustable injection comfort parameters: Injection depth, needle insertion speed, medication injection speed and time that the needle remains in the skin ; - Cartridges with 3 doses of Rebif® New Formulation; and - Several other electronic functions including history (date and time) of cartridge changes and injections. The Study Drug - Rebif® New Formulation (RNF) Rebif® is a medicine that is part of a family of proteins called interferon beta-1a (IFN-β-1a) molecules that play an important role in the immune system and help limit the damage that occurs with multiple sclerosis (MS). The interferon in Rebif® is like your body's own natural human interferon, but is made outside the body by a process called "recombinant DNA technology". Merck Serono International S.A. (the maker of Rebif®) has recently updated the method to make Rebif®, and it is referred to as Rebif® New Formulation (RNF). For the purpose of this study, the form of Rebif® New Formulation (RNF) will differ slightly from the one you currently receive. RNF will be supplied in pre-filled cartridges containing three doses of 44mcg / 0.5 ml IFN-β-1a. This is the amount required for you to administer during the course of one full week of treatment. The dosage of RNF 44mcg is injected under the skin three times per week. The RebiSmart™ device will be provided for the administration of RNF. RNF should be administered, if possible, at the same time (preferably in the late afternoon or evening) on the same three days (e.g. Monday, Wednesday, and Friday), with at least 48 hours break between each administration. You will be asked to record the time and date of each injection in the diary cards provided. You will be taught how to properly use the device to inject the medication. You will also be reminded to rotate injection sites and advised on the importance of avoiding already inflamed areas for future injections. The goals of this research trial are: - To evaluate if the electronic device can be used (if it is suitable) by MS patients performing self-injections of Rebif® New Formulation. - To determine MS patients overall satisfaction of the new RebiSmart™ device by determining their ease in using it, how often side effects happen (flu-like symptoms, injection site reactions and any other overall injection issues) that they may experience while on the trial. This will be done by completion of the Patient User Trial Questionnaire and the Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ). - To evaluate specific features of the RebiSmart™ device from the answers MS patients provide in the User Trial Questionnaire. The MS patient and the person who will trains them on the proper use of the device will complete this questionnaire.

NCT ID: NCT00734591 Completed - Diabetes Mellitus Clinical Trials

Follow-Up Study for Exubera

FUSE
Start date: August 2008
Phase: N/A
Study type: Observational

In studies of Exubera in persons with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All subjects diagnosed with lung cancer had a history of smoking and the number of lung cancer cases observed fell within the expected range based on population-based data. There is currently not enough information to determine if any of the observed lung cancer cases were related to Exubera use, therefore, the study is being conducted to further investigate whether Exubera use makes the appearance of lung cancer more likely.

NCT ID: NCT00733863 Completed - Alzheimer Disease Clinical Trials

Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.

Start date: July 2008
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mild Alzheimer's disease.

NCT ID: NCT00733421 Completed - Postoperative Pain Clinical Trials

The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery

Start date: October 2008
Phase: Phase 4
Study type: Interventional

The effects of none-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase inhibitors (Coxibs) on the formation of bone and fracture healing have been a matter of debate since long. There is, however, limited data in humans and further prospective randomised studies are warranted. Ekman et al studied in a prospective randomised double blind study the effects of celecoxib, a selective cox-II-inhibitor, on pain and bone healing following spine surgery. They found significant effects on reduction of pain and need for opioid analgesics postoperatively but could see no negative effects the numbers of "none-unions" at a 1-year follow up 3. In a similar prospective randomised double-blind study design significant effects in reduction of pain and need for rescue analgesia was seen from the use of celecoxib in the perioperative multi-modal pain strategy for cruciate-ligament reconstruction and no negative effects could bee seen on six month follow-up of the strength of the reconstructed ligament. The aim of the present study is to further study the effects of the perioperative use of etoricoxib, a selective cox-II-inhibitor (Coxibs), in a prospective randomised double-blind study on bone healing, pain and need for rescue analgesia in patients undergoing elective Hallux Valgus surgery with a standardised surgical technique including an osteotomy of metatarsale I and excision of exostosis. Study population 100 American Society of Anesthesiology (ASA) physiological status1-2 patients scheduled for elective hallux valgus (HV) surgery The patients are going to be randomised into 2 groups, 50 patients in each; 1. etoricoxib 90 mg once daily x 5 2. tramadol 100 mg twice daily x 5 First line rescue medication t. paracetamol 1 gr up to 4 gram daily Second line rescue t. oxycodone 10 mg Primary study variables: - X-ray evaluation (computer tomography (CT)-investigation) of bone healing assessed a CT-scan modelling of the osteotomy at twelve weeks after surgery - Number of patients requiring rescue medication - Patient assessment using "brief pain inventory" 24 hours and 2 weeks after surgery Secondary study variables are; - Visual Analogue Scale (VAS) grading Day 1-7 - Compliance to base medication - Need for rescue analgesia Day 1-7 - Adverse Effects - Experience of any emetic symptoms - Experience of any gastrointestinal symptoms - Satisfaction with pain medication Day 20 - Wound dressing Day 20 - Clinical evaluation 17 weeks, final assessment

NCT ID: NCT00733343 Completed - Heart Failure Clinical Trials

Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure

Serve-HF
Start date: February 2008
Phase: N/A
Study type: Interventional

The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. It is assumed that the hazard rate is constant over time.

NCT ID: NCT00731822 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study To Assess Single Dosage Strength Of GW685698/GW642444 Chronic Obstructive Pulmonary Disease (COPD)

Start date: August 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of a single dosage strength of GW685698/GW642444 in subjects with Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT00731692 Completed - Clinical trials for Primary Progressive Multiple Sclerosis

FTY720 in Patients With Primary Progressive Multiple Sclerosis

INFORMS
Start date: July 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS.

NCT ID: NCT00729898 Completed - Clinical trials for Diabetes Mellitus, Type 2

Observational Study to Observe the Safety of NovoMix® 30 Treatment in Patients With Type 2 Diabetes

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

This study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.

NCT ID: NCT00729872 Completed - Clinical trials for Moderately Active Ulcerative Colitis

A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011 in Ulcerative Colitis

Start date: July 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to verify the safety and tolerability of AG011 (genetically modified L. lactis that has been engineered to secrete human Interleukin-10), and to determine whether AG011 can successfully treat the symptoms of moderately active Ulcerative Colitis (UC).

NCT ID: NCT00729443 Completed - Healthy Volunteers Clinical Trials

Investigating Safety, Tolerability and Pharmakinetics When Giving Single and Fractionated Doses of AZD3241 to Healthy Volunteers

SAD
Start date: July 2008
Phase: Phase 1
Study type: Interventional

The study is carried out in order to investigate safety, tolerability and pharmacokinetics after administrating single and fractionated doses of AZD3241 to healthy volunteers