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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

NCT ID: NCT00729235 Completed - Clinical trials for Biventricular Tachycardias

Biventricular Tachycardias Outcome Trial

BITAC
Start date: May 2006
Phase: Phase 4
Study type: Interventional

This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone. The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable. All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows: - Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we recommend to adjust this parameter to: resting rate + 30 bpm) - VT detection rate: 150 bpm PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones. The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment. Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.

NCT ID: NCT00725985 Completed - Multiple Sclerosis Clinical Trials

Oral Cladribine in Early Multiple Sclerosis (MS)

ORACLE MS
Start date: December 31, 2008
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS.