Hartsdale

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC). This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

Researchers are evaluating CD388, a long-acting antiviral treatment, to prevent symptomatic influenza infections in adults and adolescents at higher risk for influenza complications. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess how well CD388 works compared to placebo, as well as its safety and tolerability. Participants are randomly assigned to receive either a single dose of 450 mg CD388 or a matching placebo, both given by three subcutaneous injections. The study is conducted across multiple centers and includes participants aged 12 years and older. The trial compares the incidence of influenza-like illness starting from 7 days after dosing up to 24 weeks later. During the study, participants undergo screening tests including rapid antigen tests for influenza and COVID-19 before dosing. Researchers monitor participants for influenza-like illness, collect blood samples at several visits to measure CD388 levels and immune responses, and record any side effects. The overall participation lasts up to about 24 weeks, during which adherence to study procedures and safety are closely followed.

Researchers are evaluating the effects of subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adults experiencing knee osteoarthritis (OA) pain. This randomized, double-blind, placebo-controlled phase 3 study aims to measure changes in pain and function over a treatment and follow-up period. The study involves participants with knee OA who have not responded to certain existing therapies, and the research is sponsored by Paradigm Biopharmaceuticals Ltd. Participants will be randomly assigned to receive either PPS or a placebo via subcutaneous injections twice weekly for 6 weeks. The study timeline includes a 7-week screening period, a 6-week treatment period, and a 52-week follow-up. Approximately 466 adults will be enrolled, and an interim analysis will occur after half of the participants complete Day 112, with final analyses conducted after all complete Day 404. Throughout the study, participants will visit the study center twice weekly during treatment and approximately every 4 to 6 weeks during follow-up. They will undergo assessments of knee pain using daily pain scores, function evaluations with the WOMAC index, quality of life questionnaires, and imaging tests including MRI and X-rays. Researchers will monitor safety through adverse event tracking and clinical tests. Total participation may last up to 64 weeks.

Pain management during gynecologic procedures is an important women's health issue, especially because inadequate pain control can discourage patients from seeking further care. This research investigates whether local anesthesia, specifically a lidocaine paracervical block, can reduce pain during saline infusion sonograms (SIS), a routine fertility evaluation that examines the uterus and fallopian tubes. The study compares pain experiences in women receiving lidocaine versus a placebo to better understand if local anesthesia improves comfort during SIS. Participants are randomly assigned to one of two groups: one receives a paracervical block with 10cc of 1% lidocaine buffered with sodium bicarbonate, while the other receives a placebo procedure where a capped needle is pressed against the paracervical area without injection. The trial is designed as a randomized controlled study and includes women undergoing saline infusion sonograms that assess both uterine cavity and tubal patency using a balloon catheter. Women in the study will report pain intensity at multiple points throughout the procedure, including during anesthesia administration, catheter placement, saline infusion, and after completion. The primary measurement focuses on pain during tubal patency assessment within 30 minutes of procedure start. Researchers will also monitor the need for additional devices and any inability to receive the anesthesia. The trial runs until July 2026 and aims to provide clearer guidance on pain management during fertility evaluations.

Researchers are evaluating the efficacy and safety of AZD5148, a monoclonal antibody, for preventing the recurrence of Clostridioides difficile infection in adults aged 18 years and older. This Phase IIb, randomized, double-blind, placebo-controlled study aims to understand if a single dose of AZD5148 can reduce the chance of this infection returning, which is important for individuals who have recently had a C. difficile infection. Participants will be randomly assigned to receive one dose of either AZD5148 or a placebo, administered by intramuscular injection or intravenous push, based on the investigator's choice. Approximately 230 participants will be enrolled and stratified by geographic region. The study includes up to two visits for eligibility confirmation and dosing, followed by up to seven planned visits. Researchers will maintain contact through weekly and later monthly follow-ups and collect electronic diary entries from participants. During the study, participants will undergo stool sample collection and various assessments to monitor infection recurrence and safety. The primary outcome is the first occurrence of recurrent C. difficile infection within 91 days. Secondary outcomes include clinical cure, severity and duration of symptoms, adverse events, and immune response to AZD5148. Safety monitoring will continue for up to 361 days, ensuring comprehensive follow-up throughout the study period.

Menstrual migraine is a type of headache that occurs around the time of menstruation, often causing moderate to severe pain on one side of the head, sometimes with nausea, vomiting, or sensitivity to light and sound. This trial is investigating the safety and effectiveness of ubrogepant, an oral drug, to prevent menstrual migraines. Researchers will assess changes in migraine frequency and adverse events during the study. Participants will be randomly assigned to receive either ubrogepant or a placebo once daily for 7 days starting 3 days before their expected menstrual period, repeated for three menstrual cycles during a 16-week double-blind phase. Those who qualify may continue taking ubrogepant for up to 52 weeks in an open-label extension phase. The study involves about 496 adult female participants across multiple sites in the United States and Puerto Rico. Throughout the study, participants will record daily information in electronic diaries and attend regular clinic visits. Researchers will conduct medical assessments, blood tests, and questionnaires to monitor treatment effects, side effects, and changes in disease activity. The main outcomes measured include the change in the number of migraine days during the menstrual period and the number of participants experiencing adverse events over the course of the trial.