Prairieville

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC) in this 26-week phase 3 study. The study is randomized, double-blind, and placebo-controlled, involving multiple centers. It aims to compare three doses of tenapanor (5 mg, 25 mg, and 50 mg taken twice daily) against a placebo, with a focus on improving spontaneous bowel movements. Participants will first undergo a 2-week screening where their eligibility is assessed through medical history, physical exams, lab tests, ECG, and self-reported constipation symptoms using an electronic diary (eDiary). Eligible patients will then be randomly assigned to receive one of the three doses of tenapanor or placebo twice daily for 26 weeks. During this treatment period, patients will continue daily and weekly symptom reporting via the eDiary and attend regular safety visits at weeks 2, 4, 8, 12, 16, 20, and 26. After completing the 26-week treatment, patients enter a 4-week treatment-free safety follow-up period to monitor any adverse events. A final visit occurs at the end of this follow-up to assess safety. The main outcome measured is the durable complete spontaneous bowel movements response over 12 weeks. Overall, the study involves careful monitoring of symptoms, safety, and treatment effects over approximately 32 weeks.

Researchers are investigating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid (sUA) levels in adults with hyperuricemia related to gout. This phase 3, randomized, double-blind trial focuses on adults aged 18 to 75 who have had gout for at least one year and experienced multiple gout flares in the past year. The study aims to assess the percentage of participants achieving an sUA level below 6.0 mg/dL at 24 weeks. Participants receive either dotinurad or allopurinol as oral over-encapsulated tablets. Allopurinol doses range from 200 mg/day for those with moderate kidney impairment to 600 mg/day, with participants maintaining a stable dose for at least three months before starting the study. The trial includes a 24-week treatment period where the effects of these medications on uric acid levels are monitored and compared. During the study, participants undergo regular assessments including serum uric acid measurements at screening and throughout the 24 weeks. Female participants of childbearing potential have pregnancy tests and must agree to contraception requirements. Researchers monitor safety, treatment adherence, and gout flare history to evaluate the treatments' efficacy and tolerability over the study period.

Researchers are evaluating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid (sUA) levels at 24 weeks in adults with tophaceous gout. This condition involves the presence of measurable tophi, or deposits of uric acid crystals, in joints such as hands, wrists, feet, or ankles. The study is a Phase 3, randomized, double-blind, multicenter trial focused on adults aged 18 to 75 years who have had gout for at least one year. Participants receive either dotinurad or allopurinol in over-encapsulated tablet form, taken orally. The treatments are compared to see which better lowers sUA levels below 5.0 mg/dL after 24 weeks. The study includes a screening period before treatment begins, during which eligibility is confirmed, including measurements of tophi size and uric acid levels. During the study, participants will have regular assessments to monitor serum uric acid levels and the size of tophi. Safety and side effects will also be monitored throughout the 24-week treatment period. The main outcome is the percentage of participants who achieve sUA levels less than 5.0 mg/dL at week 24, helping to understand the comparative efficacy and safety of the two medications.

Researchers are evaluating the efficacy and safety of SPN-812 (viloxazine extended release) in children aged 4 to 5 years who have Attention-Deficit/Hyperactivity Disorder (ADHD). This Phase 4 study is randomized, double-blind, placebo-controlled, and involves multiple centers. It aims to compare SPN-812 with a placebo in this preschool-age population to better understand its effects on ADHD symptoms. Participants will be randomly assigned to receive either 100 mg of SPN-812 or a placebo once daily for 6 weeks. Before treatment, there is a screening period lasting up to 4 weeks to determine eligibility. The total study duration is up to 10 weeks, including screening and treatment phases. The study uses a fixed dose and parallel-group design, meaning participants receive one treatment throughout the study. During the study, children will be assessed for changes in ADHD symptoms using a specific rating scale from the start of treatment through Week 6. Researchers will monitor safety and tolerability throughout the trial. Parents or guardians will provide consent and participate in assessments to track symptom changes and treatment effects. The study includes regular evaluations to measure ADHD symptom severity and overall clinical impression.

Researchers are conducting a Phase 3, double-blind, placebo-controlled study to evaluate the effectiveness and safety of AXS-14 (Esreboxetine) in treating fibromyalgia. The study aims to understand how well AXS-14 manages fibromyalgia symptoms and maintains therapeutic response over time. The study includes a 12-week open-label treatment period where all participants receive AXS-14 tablets once daily. Participants who respond to this treatment are then randomly assigned in a 1:1 ratio to either continue taking AXS-14 or switch to placebo tablets once daily for another 12 weeks. This randomized withdrawal period continues until 12 weeks or until a loss of therapeutic response occurs. Participants will be involved in the study for at least 24 weeks, including both treatment phases. Researchers will monitor the time from randomization to loss of therapeutic response as the primary outcome. Assessments will include safety evaluations and adherence to medication, with regular follow-ups to track symptom management and treatment effects throughout the study.