- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion date, Trial primary completion date, Adverse events: A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation (clinicaltrials.gov) - Mar 15, 2024 P3, N=116, Recruiting, Linaclotide was tolerated well in this pediatric population, showing numerical improvement in SBM frequency compared with placebo. Trial completion date: Mar 2025 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Aug 2025
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Trikafta (elexacaftor/tezacaftor/ivacaftor) / Vertex
PARTIALLY DIFFERENTIATED ILEAL AND RECTAL HUMAN CFTR-F508DEL ENTEROIDS SECRETE FLUID IN RESPONSE TO CAMP AND CGMP (140AB - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_4233; CFTR F508del can be stimulated by cAMP and cGMP in PD enterocyte populations. Our findings identify a novel role of the partially differentiated ileal and rectal enterocyte populations which behave in a way that offers the potential to improve treatment for CF constipation.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Amitiza (lubiprostone) / Takeda, Mallinckrodt
ADDING SECRETAGOGUES TO LOW VOLUME PEG IMPROVES BOWEL PREPARATION WITHOUT INCREASING SIDE EFFECTS: A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS (Hall A) - Mar 14, 2024 - Abstract #DDW2024DDW_3512; Only fully published randomized controlled trials (RCT) comparing Linaclotide and Lubiprostone in combination with PEG-based preps to other regimens in average-risk patients were included. Incorporating a secretagogue into low-volume PEG-based preparations is more likely to result in adequate and excellent bowel preparation compared to other PEG-based preparations, including low-volume 2L PEG-based solutions, and unlike other adjuncts, does not entail a significant increase in adverse events such as nausea or abdominal pain.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion date, Trial primary completion date, Adverse events: A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide (clinicaltrials.gov) - Mar 5, 2024 P2, N=30, Recruiting, It can facilitate high-quality bowel preparation, reduce the incidence of nausea during the bowel preparation procedure, and encourage patients to undertake repeated bowel preparation. Trial completion date: Dec 2024 --> Sep 2025 | Trial primary completion date: Apr 2024 --> Sep 2025
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion, Trial completion date, Trial primary completion date: Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy (clinicaltrials.gov) - Jan 16, 2024 P=N/A, N=1513, Completed, No abstract available Recruiting --> Completed | Trial completion date: Feb 2023 --> Sep 2023 | Trial primary completion date: Dec 2022 --> Aug 2023
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Review, Journal: Fundamental Neurochemistry Review: The role of enteroendocrine cells in visceral pain. (Pubmed Central) - Dec 22, 2023 While this brings some clarity to the relationship between linaclotide and visceral analgesia, questions remain about the intracellular signaling mechanisms and neurotransmitters mediating this communication. In this Fundamental Neurochemistry Review, we discuss what is currently known about visceral nociceptors, enteroendocrine cells, and the gut-brain axis, and ongoing areas of research regarding that axis and visceral pain.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
New trial: Effects of linaclotide combined with polyethylene glycol in bowel preparation for colonoscopic polypectomy: A randomized controlled trial. (EUDRACT) - Dec 5, 2023 P=N/A, N=422, Not yet recruiting, In this Fundamental Neurochemistry Review, we discuss what is currently known about visceral nociceptors, enteroendocrine cells, and the gut-brain axis, and ongoing areas of research regarding that axis and visceral pain. .
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Trulance (plecanatide) / Bausch Health
Preclinical, Journal: The evolutionary divergence of receptor guanylyl cyclase C has implications for preclinical models for receptor-directed therapeutics. (Pubmed Central) - Nov 30, 2023 These altered properties are reflected in the high concentrations of ligands required to elicit signaling responses in the mouse gut in preclinical models and the specificity of a guanylyl cyclase inhibitor towards human GC-C. Therefore, our studies identify considerations in using the murine model to test molecules for therapeutic purposes that work as either agonists or antagonists of GC-C, and vaccines for the bacterial heat-stable enterotoxin that causes watery diarrhea in humans.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Journal: Cost impact of incorporating linaclotide into low-volume colonoscopy preparation. (Pubmed Central) - Nov 3, 2023 Therefore, our studies identify considerations in using the murine model to test molecules for therapeutic purposes that work as either agonists or antagonists of GC-C, and vaccines for the bacterial heat-stable enterotoxin that causes watery diarrhea in humans. No abstract available
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Resolor (prucalopride) / J&J, Takeda, Amitiza (lubiprostone) / Takeda, Mallinckrodt
Review, Journal: Recommendations for the management of opioid-induced constipation - how to improve usability in clinical practice. (Pubmed Central) - Nov 3, 2023 It was validated in primary care for credibility, clarity, relevance, usability, and overall benefit. We believe that this initiative can lead to better management of the substantial proportion of patients suffering from side effects of opioids.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion date, Trial primary completion date: Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC) (clinicaltrials.gov) - Nov 1, 2023 P3, N=426, Recruiting, In that context, GUCY2C ligands linaclotide (Linzess Trial completion date: Apr 2024 --> Sep 2024 | Trial primary completion date: Mar 2024 --> Sep 2024
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion date, Trial primary completion date: Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C (clinicaltrials.gov) - Oct 30, 2023 P3, N=120, Enrolling by invitation, Trial completion date: Apr 2024 --> Sep 2024 | Trial primary completion date: Mar 2024 --> Sep 2024 Trial completion date: Jul 2024 --> Oct 2025 | Trial primary completion date: Jul 2024 --> Oct 2025
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion date, Trial primary completion date, Adverse events: A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation (clinicaltrials.gov) - Sep 28, 2023 P3, N=100, Recruiting, Trial completion date: Jul 2024 --> Oct 2025 | Trial primary completion date: Jul 2024 --> Oct 2025 Trial completion date: Aug 2024 --> Mar 2025 | Trial primary completion date: Aug 2024 --> Nov 2024
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Journal: Linaclotide (Linzess) for functional constipation. (Pubmed Central) - Aug 31, 2023 This study supports incorporation of microbiota and metabolomic assessment to improve precision medicine for DGBI patients. No abstract available
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Trulance (plecanatide) / Bausch Health, Resolor (prucalopride) / J&J, Takeda
Sudden Onset Persistent Colonic Hypomotility After Laparoscopic Sleeve Gastrectomy (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_3857; Bariatric patients with colonic motility dysfunction after LSG should be identified and their pathophysiology should be further explored in order to limit procedure complications, reduce health care costs, and improve quality of life. Figure: Image 1: CT Showing Recurrent Significant Right-Sided Colonic Stool Burden
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial initiation date, Combination therapy: IBSC-VR: A Study of Virtual Reality and Linaclotide for IBS-C (clinicaltrials.gov) - Jul 28, 2023 P=N/A, N=65, Not yet recruiting, There were no significant differences in MCS compared to control in participants with IBS-C or CIC taking linaclotide who were satisfied with control of their bowel, abdominal, or both of their symptoms ( Table ). Initiation date: Jun 2023 --> Sep 2023
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Amitiza (lubiprostone) / Takeda, Mallinckrodt
Clinical guideline, Review, Journal: 2022 Seoul Consensus on Clinical Practice Guidelines for Functional Constipation. (Pubmed Central) - Jul 7, 2023 The guidelines consist of 34 recommendations, including 3 concerning the definition and epidemiology of functional constipation, 9 regarding diagnoses, and 22 regarding managements. Clinicians (including primary physicians, general health professionals, medical students, residents, and other healthcare professionals) and patients can refer to these guidelines to make informed decisions regarding the management of functional constipation.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial primary completion date: Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC) (clinicaltrials.gov) - Jun 29, 2023 P3, N=426, Recruiting, Clinicians (including primary physicians, general health professionals, medical students, residents, and other healthcare professionals) and patients can refer to these guidelines to make informed decisions regarding the management of functional constipation. Trial primary completion date: Jul 2023 --> Mar 2024
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