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 dotinurad, an oral drug, to lower serum uric acid levels in adults with gout who cannot tolerate xanthine oxidase inhibitors XOI or whose uricase treatment has failed. This Phase 2 randomized, double-blind, placebo-controlled study aims to assess the drugs effectiveness and safety in this specific population. The primary goal is to see how many participants achieve a serum uric acid level below 6.0 mgdL at 24 weeks. Participants will be divided into two groups. One group will take dotinurad for 36 weeks, split into a 24-week initial period followed by a 12-week continuation. The other group will take a placebo for the first 24 weeks and then switch to dotinurad for the final 12 weeks. Dotinurad is given as an oral tablet, while the placebo capsules contain inactive ingredients. This design allows comparison of the drug against placebo and later observation of dotinurads effects. During the study, participants will have their serum uric acid measured at various points, especially at weeks 16, 20, 24, and up to week 40. Researchers will monitor treatment-emergent adverse events throughout the study period. Participants will be followed from screening through treatment and safety assessments, with the primary focus on uric acid levels at week 24. The total study duration for each participant covers screening and up to 40 weeks of follow-up.

Researchers are studying the effects of camlipixant in adults with two types of irritable bowel syndrome IBS-D diarrhea-predominant and IBS-M mixed type. This Phase 2b trial aims to assess how well camlipixant works and how safe it is when compared to a placebo. The study includes two parts, where after the first part, some participants may be randomly assigned to receive a higher dose of camlipixant or stop taking the drug. Participants receive camlipixant at different dose levels or a placebo during the first part of the study. In the second part, all participants are randomized again to either continue with camlipixant or placebo. The treatment lasts up to 26 weeks, with doses adjusted in the second phase. The study uses a triple-blind design where neither participants nor researchers know who receives which treatment during the trial. During the study, participants will regularly report their abdominal pain intensity and stool form using specific scoring systems. Researchers will monitor safety by tracking adverse events and changes in vital signs and laboratory tests. The main outcome measures focus on changes in abdominal pain intensity over weeks 7 to 12. Participants will be assessed throughout the 26-week period to evaluate the treatments effects and safety.

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.

Researchers are conducting a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-14 esreboxetine in managing fibromyalgia. The study aims to understand how well AXS-14 works for people with fibromyalgia by comparing continued treatment to placebo after an initial response. This multi-center trial is sponsored by Axsome Therapeutics, Inc. The study includes a 12-week open-label period where all participants receive AXS-14 tablets once daily. Those who respond to treatment will then enter a 12-week double-blind, placebo-controlled randomized withdrawal period. During this phase, participants are randomly assigned to either continue AXS-14 or switch to placebo until a loss of therapeutic response occurs or the period ends. Participants will be closely monitored throughout both study periods. Researchers will assess the time from randomization to loss of therapeutic response over 12 weeks. The study involves regular evaluations to track safety and treatment effects. Total participation spans up to 24 weeks, including both treatment phases.

Pain management during gynecologic procedures, especially saline infusion sonograms SIS used in fertility evaluations, is an important womens health issue as inadequate pain control may cause avoidance of necessary care. This trial evaluates whether local anesthesia using a lidocaine paracervical block reduces pain during SIS compared to a placebo procedure in women undergoing uterine and tubal assessments. The goal is to improve the patient experience and accessibility of SIS in fertility care. Participants are randomly assigned to receive either a paracervical block with 10cc of 1% lidocaine buffered with sodium bicarbonate or a placebo where a capped needle mimics injection without anesthesia. The study compares self-reported pain scores at multiple points during the procedure, including during the block administration, balloon catheter placement, saline infusion, and up to one hour after the procedure. This is a Phase 4, single-blind, parallel-group study. Women enrolled undergo saline infusion sonograms with balloon catheter assessments after taking ibuprofen beforehand. Researchers collect pain ratings during and after the procedure, record procedural details such as use of tenaculum or uterine sound, and monitor any inability to receive the block. The study measures changes in pain intensity during tubal patency assessment as the primary outcome and includes multiple secondary pain intensity measures. The trial runs from July 2025 to July 2027.

Researchers are evaluating the efficacy and safety of AZD5148, a monoclonal antibody, for preventing the recurrence of Clostridioides difficile infection in adults aged 18 and older. This Phase IIb study aims to compare a single dose of AZD5148 with a placebo to better understand its potential role in reducing recurrent infections. The study involves approximately 230 participants randomized equally to receive either the active drug or placebo. Participants will receive one dose of AZD5148 or placebo, administered either by intramuscular injection or intravenous push based on the investigators choice. The study includes up to two site visits for eligibility confirmation and dose administration, including stool sample collection. Following treatment, there will be up to seven planned visits with weekly contacts initiated by the study staff, transitioning later to monthly follow-ups. Participants will also complete an electronic diary to record relevant information. During the study, participants will undergo various assessments including stool testing, monitoring of diarrhea symptoms, and evaluation of any recurrence of infection up to 91 days after dosing. Safety assessments will include monitoring for immediate and delayed adverse events, injection site reactions, and serious adverse events up to 361 days. Pharmacokinetics and immune response to AZD5148 will also be evaluated. The total participation period spans from initial screening through follow-up visits extending up to nearly one year after treatment.