The primary endpoint will be the percent reduction in need for narcotic analgesics from baseline to the end of the study, compared to placebo, while secondary endpoints will include electronic diary-captured assessments of menstrual, nonmenstrual and intercourse-related pain recorded using a validated instrument...The primary endpoint of the trial is the proportion of patients able to be discharged alive from the hospital within 28 days following the trauma

The primary endpoint of bacterial eradication, as measured by conversion from positive baseline urethral or cervical cultures to negative at seven days, was achieved in 100 percent of evaluable patients (22 patients with positive baseline cultures...The primary endpoints will be progression-free survival in all patients, as well as in patients who have a particular biomarker

Started in March, the Eslicarbazepine acetate in Partial-Onset Seizures study is intended to enroll about 800 patients, with a primary endpoint of six-month retention rate and other assessments, including seizure frequency, adverse events and quality of life

The primary endpoint will be to evaluate survival in second-line therapy...The 24-week study achieved statistical significance for all co-primary endpoints testing weekly reductions in the frequency and severity of VMS, except for severity of VMS symptoms at week 12

The primary endpoint in the second stage will be a comparison of progression-free survival, and secondary endpoints will assess response rate and overall survival...Genzyme Corp., of Cambridge, Mass., a unit of Sanofi SA, of Paris, reported that ENGAGE, the first Phase III trial of its investigational oral therapy, eliglustat tartrate, met its primary endpoint in previously untreated Gaucher disease Type I. Patients treated with eliglustat tartrate had a statistically significant improvement in

The primary endpoint is the annual rate of decline in forced vital capacity, while secondary endpoints include health-related quality of life, exacerbations, respiratory mortality, overall survival and on-treatment survival

The primary endpoint is overall response rate, and interim data are expected by the end of this year

Clarus Therapeutics Inc., of Northbrook, Ill., said top-line data from the 90-day treatment phase of its ongoing Phase III study of CLR-610, an oral testosterone replacement product, demonstrated that 87 percent of the 141 men treated with CLR-610 achieved average serum T levels in the normal range (between 300 ng/dL and 1,000 ng/dL), the study's primary endpoint...The primary endpoint is progression-free survival, with secondary endpoints of overall survival, safety and tolerability

Approximately 1,000 patients are enrolled in the pivotal INPULSIS Phase III trials at sites in 23 countries, with a primary endpoint of the annual rate of decline in forced vital capacity over 52 weeks

The open-label trial will enroll about 40 patients chronically infected with HCV genotype-1a, and the primary endpoint will be sustained virologic response 12 weeks after the end of treatment

The NETTER-1 study will compare Lutathera to Sandostatin LAR (octreotide, Novartis AG) in patients and will measure progression-free survival as the primary endpoint...The 28-day ascending-dose study will test the drug's safety as the primary endpoint, while secondary endpoints will look at decreased retinal thickness as measured by optical coherence tomography, as well as improved visual acuity and selected biomarkers

The primary endpoint is the change from baseline in the Hamilton Anxiety Rating scale score, with secondary endpoints including change from baseline of several other clinician-administered rating scales designed to assess the severity of depression and anxiety symptoms...The data suggested ORAL Start (A3921069), an ongoing Phase III, two-year study in methotrexate (MTX)-naïve patients with moderate-to-severe active RA randomized to tofacitinib 5 mg or 10 mg twice daily as monotherapy or MTX, met

The primary endpoint compares changes in HbA1c, while secondary endpoints compare postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes

The primary endpoint will be the change in mean pre-bronchodilator forced expiratory volume from baseline...Santarus Inc., of San Diego, said its 264-patient Phase III study testing rifamycin SV MMX met the primary endpoint of reducing time to last unformed stool (TLUS) in subjects with travelers' diarrhea

Eli Lilly and Co., of Indianapolis, said the Phase III POINTBREAK trial did not meet its primary endpoint of improved overall survival for patients with nonsquamous non-small-cell lung cancer who were randomized to receive a combination of Alimta (pemetrexed) with Avastin (bevacizumab, Roche AG) and carboplatin induction followed by Alimta plus Avastin maintenance, compared to the combination of paclitaxel with Avastin and carboplatin followed by Avastin maintenance

The primary endpoint is a change in interstitial capillary GL-3 as measured by kidney biopsy at six months vs...The pivotal study is being conducted under an FDA special protocol agreement, with a primary endpoint of early response measured 48 hours to 72 hours after initiation of therapy. (See BioWorld Today, March 26, 2012, and July 20, 2012

A total of 198 patients have been enrolled, and the primary endpoint is antipsychotic efficacy as measured using nine items from the hallucinations and delusions domains of the Scale for the Assessment of Positive Symptoms...The primary endpoint of the study is the time to occurrence of major adverse cardiovascular events during randomized treatment for Contrave compared to placebo

The company previously reported top-line data from the study, which missed its primary endpoint of reduced day 180 bronchiolitis obliterans syndrome in an intent-to-treat (ITTc) analysis, but achieved statistical significance in prospectively defined analyses of ITTc patients with their last observation carried forward and of ITTc patients treated per protocol

Sosei Group Corp., of Tokyo, said QVA149 (indacaterol maleate/glycopyrronium bromide) met the primary endpoint in its fifth Phase III trial, which enrolled more than 2,000 subjects