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Tag: "tolerability" at medical news

Maxygen Initiates Phase IIa Clinical Trial of MAXY-G34 in Breast Cancer Patients

...ase IIa trial to evaluate the efficacy, safety and tolerability of MAXY-G34 in the treatment of chemotherapy-induc... was previously conducted to assess the safety and tolerability of MAXY-G34 in 40 healthy volunteers. This study showed MAXY-G34 to be a potent, long-lasting stimul...

Napo Obtains Special Protocol Assessment Agreement From FDA for Crofelemer

... the extension is to provide additional safety and tolerability information about crofelemer in longer tem use. Commenting on this announcement, Lisa Conte, Chief Executive Officer of Napo Pharmaceuticals, said: "The SPA agreement is an important milestone for Napo, allowing us to address and mitigate regulator...

BioCryst Receives Special Protocol Assessment for Fodosine

...condary endpoints include assessing the safety and tolerability of extended daily treatment with oral Fodosine(TM), assessment of the time to objective response and the duration of objective response. "We are pleased to have reached agreement with the FDA in a timely manner. Receipt of this SPA is an important ...

Implanon,norplant,Jadelle - Vary in Side Effects

...eview that set out to assess the effectiveness and tolerability of subdermal implantable contraceptives compared ...long period of time, there are indications of good tolerability in that over 80% of women in the studies continued to use their contraceptive implants for two or mo...

Galvus Soon To Be Seen On European Shelves

...r levels under control, therefore the efficacy and tolerability of Galvus in combination with other medicines is especially significant. As of now, Novartis expects to resubmit its Galvus diabetes treatment for U.S. approval around the middle of 2009, while starting a new study later this year. "It (the study) ...

Phase II Data Show Efficacy and Tolerability of Tapentadol in Chronic Pain Treatment

...d the first clinical evidence for the efficacy and tolerability of tapentadol ER (extended release) for patients s...the current findings confirm tapentadol's improved tolerability compared to other strong centrally acting analgesics like oxycodone, and morphine. "With currentl...

Modified Drug Therapy for Alzheimers Disease

...sed of 48 healthy volunteers, will measure safety, tolerability and pharmacokinetics of CTS-21166 at various doses. The company expects to begin generating human clinical data by the end of 2007 and to begin phase II studies in Alzheimer's patients in 2008. The drug could be administered at any stage of the disea...

Novagali Pharma Presents Phase III Clinical Trial of Vekacia(R) for Vernal Keratoconjunctivitis

...in patients receiving Vekacia(R). Furthermore, the tolerability of Vekacia(R) was excellent. The study was designed as a clinical phase II/III, multicenter, randomized parallel group, double masked, dose ranging, controlled study divided in two treatment periods: (I) a four-week prospective, randomized, multice...

Replidyne Announces Positive Phase I Results for Topical Antibiotic REP8839

... 400 subjects. In the first Phase I trial, safety, tolerability and skin irritancy were tested following repeated ...cts. In the second study, in addition to safety, tolerability and dermal irritancy, systemic exposure was examined following repeated daily application of REP8839...

INVEGA Receives Marketing Authorization In EU For Treatment Of Schizophrenia

...ind, placebo controlled study assessing safety and tolerability in 114 elderly patients suffering from schizophren...e of functional improvement, as well as safety and tolerability assessments, were also included in the trials that supported the approval of INVEGA. The recommended...

INVEGA(TM) Gets Marketing Authority from EU to Treat Schizophrenia

...ind, placebo controlled study assessing safety and tolerability in 114 elderly patients suffering from schizophren...e of functional improvement, as well as safety and tolerability assessments, were also included in the trials that supported the approval of INVEGA. The recommended...

Surface Logix Commences Phase 2a Clinical Trial of SLx-2101 in Raynaud's Disease

...ease. The trial is designed to examine the safety, tolerability and pharmacodynamic profile of repeat oral doses o...d attacks during the dosing period, the safety and tolerability of SLx-2101, and the effect of the drug on capillary blood flow velocity and vasospastic symptoms. ...

Novartis Drug Diovan Shows Superior Benefits

...percent overall) with no significant difference in tolerability between the groups. According to investigators, these effects were reported independently of blood pressure reductions. Says Gordon McInnes, Professor of Medicine at the Western Infirmary in Glasgow, Scotland:"The results of this trial carry an im...

Crucell's Rabies MAb Enters Phase I Trial in India

...ain parameters under investigation will be safety, tolerability and rabies virus neutralizing activity. “We ar... trial, as it follows favorable interim safety and tolerability data from the initial US study. The clinical testing of the Rabies antibody cocktail in Asia is the ...

New Therapy to Treat Patients With Severely Elevated Cholesterol Levels

...ted a dose-escalation study to examine the safety, tolerability and effects on lipid levels of an inhibitor of MTP in six patients with homozygous FH. Patients received the MTP inhibitor at four different doses, each for four weeks, and returned for a final visit after an additional four-week drug washout period....

Tegaserod offers relief for Chronic Constipation

...fit millions.” The long-term safety, efficacy and tolerability of tegaserod have been proven. Patients show no serious side-effects from long-term usage and maximal improvements were observed after approximately 6 months of further treatment and were sustained thereafter. Source-Eurekalert<BRMST...

International Collaboration Takes Aim at Rabies

...al trial in India in 2007 to assess the safety and tolerability of the new MAB in people, with hopes of having the new, lower-cost treatment available within two years for people exposed to rabies. The treatment would then be made broadly available in India shortly thereafter. “Rabies is a major global public h...

Patients suffering ED happy with Vardenafil drugs

...of which have previously demonstrated efficacy and tolerability in a range of patient populations, according to researchers. Data from head-to-head clinical trials, like this one, are scarce. However, results from studies such as this should help clinicians to differentiate among sildenafil, vardenafil, and tada...

Exubera is effective in diabetes patients with cold or flu

...tudy of Diabetes. "It shows that the efficacy and tolerability of Exubera remain unchanged even if patients develop a cold or the flu. Also, studies showed patients taking Exubera are no more likely to develop a respiratory infection than patients using injectable insulin," he added. Examination of 5 other cli...

Analysis Shows Lamictal As An Effective Additional Therapy For Treatment of Grand Mal Seizures

...led study was conducted to assess the efficacy and tolerability of adjunctive therapy with LAMICTAL in the treatme... years of age and was associated with a favourable tolerability profile. ABOUT EPILEPSY Epilepsy, defined by recurrent unprovoked seizures, is a change in sensati...

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