- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
[VIRTUAL] A NOVEL SCORE TO EVALUATE ABDOMINAL SYMPTOM IMPROVEMENT IN PATIENTS WITH CONSTIPATION-PREDOMINANT IBS DEMONSTRATES EFFICACY OF LINACLOTIDE FOR IMPROVING ABDOMINAL BLOATING, DISCOMFORT, AND PAIN IN A PHASE 3B TRIAL (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_4817;
Linaclotide significantly improved multiple abdominal symptoms important to IBS-C patients (abdominal bloating, discomfort, and pain) compared with placebo, as measured by a novel, multi-item abdominal score. The AS, derived from the abdominal symptom items in the DIBSS-C, should be used in future IBS-C clinical studies to measure clinically meaningful improvements in these three abdominal symptoms in IBS.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
[VIRTUAL] A NOVEL SCORE TO EVALUATE ABDOMINAL SYMPTOM IMPROVEMENT IN PATIENTS WITH CONSTIPATION-PREDOMINANT IBS DEMONSTRATES EFFICACY OF LINACLOTIDE FOR IMPROVING ABDOMINAL BLOATING, DISCOMFORT, AND PAIN IN A PHASE 3B TRIAL (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_2841;
Linaclotide significantly improved multiple abdominal symptoms important to IBS-C patients (abdominal bloating, discomfort, and pain) compared with placebo, as measured by a novel, multi-item abdominal score. The AS, derived from the abdominal symptom items in the DIBSS-C, should be used in future IBS-C clinical studies to measure clinically meaningful improvements in these three abdominal symptoms in IBS.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
[VIRTUAL] A NOVEL SCORE TO EVALUATE ABDOMINAL SYMPTOM IMPROVEMENT IN PATIENTS WITH CONSTIPATION-PREDOMINANT IBS DEMONSTRATES EFFICACY OF LINACLOTIDE FOR IMPROVING ABDOMINAL BLOATING, DISCOMFORT, AND PAIN IN A PHASE 3B TRIAL (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_857;
Linaclotide significantly improved multiple abdominal symptoms important to IBS-C patients (abdominal bloating, discomfort, and pain) compared with placebo, as measured by a novel, multi-item abdominal score. The AS, derived from the abdominal symptom items in the DIBSS-C, should be used in future IBS-C clinical studies to measure clinically meaningful improvements in these three abdominal symptoms in IBS.
- |||||||||| Retrospective data, Review, Journal: Efficacy of drugs in chronic idiopathic constipation: a systematic review and network meta-analysis. (Pubmed Central) - May 28, 2020
Prucalopride ranked first at 12 weeks, and many of the included trials recruited patients who previously did not respond to laxatives, suggesting that this drug is likely to be the most efficacious for patients with chronic idiopathic constipation. However, because treatment duration in most trials was 4-12 weeks, the long-term relative efficacy of these drugs is unknown.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Enrollment open: Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C (clinicaltrials.gov) - May 26, 2020
P3, N=120, Enrolling by invitation,
physiologic and pathophysiologic insight gained by evaluation "physiologic redundancy" and "conservation of function". Active, not recruiting --> Enrolling by invitation
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Enrollment open: 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) - May 26, 2020
P3, N=326, Recruiting,
Active, not recruiting --> Enrolling by invitation Active, not recruiting --> Recruiting
- |||||||||| Clinical, Journal: Table: Safety of drugs for IBS in pregnancy and lactation (online only). (Pubmed Central) - Apr 25, 2020
Consistent with previously published evidence, multiple analyses support a two-point improvement on the AS of the DIBSS-C as a clinically meaningful treatment benefit for IBS-related abdominal symptoms useful for identifying individual treatment responders among IBS-C clinical trial subjects. No abstract available
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood Pharma
Biomarker, Journal: What's in the pipeline for lower functional gastrointestinal disorders in the next 5 years? (Pubmed Central) - Apr 10, 2020
Chronic abdominal pain remains an unmet need in patients with lower FGIDs, and promising novel approaches include delayed-release linaclotide, non-classical opioid visceral analgesics and selective cannabinoid receptor agonists. The role of probiotics, fecal microbial transplantation and possible future microbiome therapies is discussed.
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood Pharma, sildenafil / Generic mfg.
Review, Journal: Targeting the Paracrine Hormone-Dependent Guanylate cyclase/cGMP/Phosphodiesterases Signaling Pathway for Colorectal Cancer Prevention. (Pubmed Central) - Apr 5, 2020
Thus, GUCY2C agonists, such as linaclotide, exhibit considerable role in preventing CRC tumorigenesis...PDE5-specific inhibitors, such as sildenafil, show considerable anti-tumorigenic potential against CRC by amplifying the GUCY2C/cGMP signaling pathway, but cannot achieve complete anti-tumorigenic effects...Further, the events are associated with dysregulation of this pathway during CRC tumorigenesis are also discussed. In addition, current updates on targeting the GUCY2C/cGMP/PDEs pathway with GUCY2C agonists and PDEs inhibitors for CRC prevention and treatment are described in detail.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Enrollment closed: 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) - Mar 30, 2020
P3, N=326, Active, not recruiting,
Enrolling by invitation --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood Pharma
[VIRTUAL] ESTIMATING HEALTH-STATE UTILITY VALUES IN IRRITABLE BOWEL SYNDROME WITH CONSTIPATION USING THE EQ-5D-5L () - Mar 8, 2020 - Abstract #ISPOR2020ISPOR_1309;
Patients with IBS-C have deteriorated health related quality of life, with pain/discomfort and anxiety/depression as the most frequently reported problems. This study provides new insights into variations in health-state utility values from a single source that can be used to inform cost-effectiveness evaluations in patients with IBS-C.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion date, Trial primary completion date: Assessment of Responsiveness to Treatment by Experience Sampling Method (clinicaltrials.gov) - Feb 27, 2020
P=N/A, N=30, Recruiting,
This study provides new insights into variations in health-state utility values from a single source that can be used to inform cost-effectiveness evaluations in patients with IBS-C. Trial completion date: Dec 2018 --> Mar 2021 | Trial primary completion date: Dec 2018 --> Jan 2021
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial primary completion date: The Psychosocial Effects of Systemic / Family Constellation (clinicaltrials.gov) - Feb 25, 2020
P=N/A, N=200, Recruiting,
Trial completion date: Dec 2018 --> Mar 2021 | Trial primary completion date: Dec 2018 --> Jan 2021 Trial primary completion date: Aug 2019 --> Jun 2020
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion date, Trial primary completion date: Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation (clinicaltrials.gov) - Feb 24, 2020
P4, N=23, Active, not recruiting,
Trial primary completion date: Aug 2019 --> Jun 2020 Trial completion date: Jan 2020 --> Jan 2021 | Trial primary completion date: Oct 2019 --> Oct 2020
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Enrollment closed, Trial completion date, Trial primary completion date: Cognitive and Psychiatric Effects of Linaclotide on Patients With Constipation (clinicaltrials.gov) - Feb 19, 2020
P=N/A, N=100, Active, not recruiting,
Trial completion date: Jan 2020 --> Jan 2021 | Trial primary completion date: Oct 2019 --> Oct 2020 Recruiting --> Active, not recruiting | Trial completion date: Dec 2018 --> Mar 2021 | Trial primary completion date: Dec 2018 --> Dec 2020
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Enrollment status: Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C (clinicaltrials.gov) - Feb 13, 2020
P3, N=120, Enrolling by invitation,
Recruiting --> Active, not recruiting | Trial completion date: Dec 2018 --> Mar 2021 | Trial primary completion date: Dec 2018 --> Dec 2020 Recruiting --> Enrolling by invitation
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood Pharma, Relistor (methylnaltrexone bromide) / Ono Pharma, Progenics, Bausch Health
Treatment of Severe Constipation In Chronic Spinal Cord Injury with Pyridostigmine: A Case Report () - Feb 11, 2020 - Abstract #ISPRM2020ISPRM_1809;
Patient had limited function to manage a cecostomy or ileostomy independently on days when she had no caregiver support. In this case, pyridostigmine treatment resulted in clinical improvement in bowel function and quality of life.Conclusions : In severe cases of neurogenic constipation in SCI refractory to standard management, pyridostigmine may be considered as an alternative prior to pursuing surgery.
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood Pharma, Trulance (plecanatide) / Synergy Pharmaceuticals Inc., Amitiza (lubiprostone) / Takeda, Mallinckrodt
Journal: Recent advances in the pharmacological management of constipation predominant irritable bowel syndrome. (Pubmed Central) - Feb 7, 2020
Drugs present on the market as well as those in pre-clinical development should increase the lower esophageal sphincter pressure, promote gastric motility, accelerate gastric emptying and improve gastro-duodenal coordination. Most significantly, they shall not induce severe side effects.
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood Pharma
Clinical, Journal: IBS clinical management in Italy: The AIGO survey. (Pubmed Central) - Jan 30, 2020
IBS diagnosis is still largely based on exclusion criteria even if gastroenterologists try to improve diagnostic appropriateness. However, therapy remains symptom-based also in the gastroenterological setting even if gastroenterologists use a wide variety of approaches, including innovative therapies such as linaclotide and psychotherapy.
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood Pharma
A NOVEL SCORE TO EVALUATE ABDOMINAL SYMPTOM IMPROVEMENT IN PATIENTS WITH CONSTIPATION-PREDOMINANT IBS DEMONSTRATES EFFICACY OF LINACLOTIDE FOR IMPROVING ABDOMINAL BLOATING, DISCOMFORT, AND PAIN IN A PHASE 3B TRIAL () - Jan 28, 2020 - Abstract #DDW2020DDW_3139;
Linaclotide significantly improved multiple abdominal symptoms important to IBS-C patients (abdominal bloating, discomfort, and pain) compared with placebo, as measured by a novel, multi-item abdominal score. The AS, derived from the abdominal symptom items in the DIBSS-C, should be used in future IBS-C clinical studies to measure clinically meaningful improvements in these three abdominal symptoms in IBS.
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood Pharma
CHRONIC INTRA-COLONIC LINACLOTIDE ADMINISTRATION ALTERS GLIAL ACTIVATION IN A MOUSE MODEL OF CHRONIC VISCERAL HYPERSENSITIVITY () - Jan 28, 2020 - Abstract #DDW2020DDW_2906;
Reducing the influence of glia in these sensory structures could reduce pain originating from the colon in CVH states.These results complement our previous findings in mice1,2 and provide further mechanistic insight into how linaclotide, through GC-C agonism and the release of cGMP from mucosal epithelial cells, reduces nociceptive signaling from the colon to the CNS1,2,3. 1Gastroenterology,2013, Dec;145(6):1334-46.
- |||||||||| Journal: Constipation - pathophysiology, diagnostics, treatment (Pubmed Central) - Jan 12, 2020
Their selection depends on the individual preference of the patient. Opioids often induce constipation which can be ameliorated by laxatives or PAMORAs (peripherally acting µ-opioid antagonists).
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