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4 Linaclotide Trials Near You
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerLinaclotide for Pediatric Constipation
Cleveland, Ohio
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC.
Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients, ages 2 to 5, who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. All participants in Part 2 will receive linaclotide. Approximately 116 participants aged 2 to 5 years with FC will be enrolled in this study at around 45 sites worldwide.
Participants will receive daily doses of oral Linaclotide capsules or matching placebo for 12 weeks in Part 1 of the study. In Part 2, the open label long-term safety extension, participants with FC who completed study intervention in Part 1 of Study M21-572 or the Phase 2 Study LIN-MD-67 will receive linaclotide for 24 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:2 - 5
Sex:All
Key Eligibility Criteria
Disqualifiers:Celiac, Cystic Fibrosis, Hypothyroidism, Others
123 Participants Needed
Linaclotide for Pediatric Constipation
Farmington Hills, Michigan
This trial tests linaclotide, a medication that may help young children with constipation by making their stools softer and easier to pass. The study involves children aged 6 months to less than 2 years who struggle with constipation.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:6 - 23
Sex:All
Key Eligibility Criteria
Disqualifiers:Celiac, Cystic Fibrosis, Hypothyroidism, Others
Must Not Be Taking:Laxatives, Suppositories, Enemas
30 Participants Needed
Plecanatide + Linaclotide for Digestive Health
Madison, Wisconsin
This early phase I trial studies the guanylyl cyclase C (GCC) agonist effect on cGMP signal in duodenal tissue. Plecanatide and linaclotide are drugs approved by the Food and Drug Administration for the treatment of conditions related to constipation. This trial aims to see the effects of taking either one of two drugs, plecanatide or linaclotide, or no drug, on a certain chemical found in the tissue collected from small intestine and how they compare.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Gastric Surgery, Allergic Reactions, Others
Must Not Be Taking:GCC Agonists, Investigational Agents
43 Participants Needed
Linaclotide for Colorectal Cancer
Philadelphia, Pennsylvania
This trial studies how well linaclotide works in patients with early-stage colorectal cancer. Linaclotide helps the intestines release water and salt by binding to cell receptors. Researchers want to see if it affects cancer-related markers. Linaclotide is an FDA-approved drug primarily used for treating chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C).
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 80
Sex:Female
Key Eligibility Criteria
Disqualifiers:Gastroparesis, Celiac, Inflammatory Bowel, Others
Must Not Be Taking:Linaclotide, Investigational Agents
230 Participants Needed
Learn More About Power
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Bask GillCEO at Power
Frequently Asked Questions
How much do clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.How do clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length is 12 months.How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.Do I need to be insured to participate in a medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.What are the newest clinical trials ?
Most recently, we added Linaclotide for Pediatric Constipation, Linaclotide for Pediatric Constipation and Plecanatide + Linaclotide for Digestive Health to the Power online platform.Popular Searches
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