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- | Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
Journal: Randomised clinical trial: effects of MD-7246 on irritable bowel syndrome with diarrhoea. (Pubmed Central) - Nov 4, 2022
MD-7246 at the doses studied did not improve abdominal pain relative to placebo in an IBS-D patient population. Similarly, most additional efficacy endpoints showed no improvement with MD-7246 relative to placebo.
- Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
[VIRTUAL] IMPACT OF MD-7246 ON IRRITABLE BOWEL SYNDROME WITH DIARRHEA: PHASE 2 RESULTS (DDW Virtual) - Mar 15, 2021 - Abstract #DDW2021DDW_4487;
MD-7246 did not show significant benefit when compared to placebo in patients with IBS-D. The effect seen in the subset of patients with longer diagnosis time is intriguing and should be explored further.
- ||| Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
Enrollment change: A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome (clinicaltrials.gov) - Mar 12, 2021
P2, N=515, Completed, Sponsor: Ironwood Pharmaceuticals, Inc.
The effect seen in the subset of patients with longer diagnosis time is intriguing and should be explored further. N=388 --> 515
- || Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
Clinical, Journal: Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation. (Pubmed Central) - Mar 2, 2021
Altering the site of drug delivery in the intestine might uncouple linaclotide's pain relief from secretory effects. Persistent, modest abdominal pain improvement with limited impact on bowel symptom parameters, as seen across MD-7246 doses, warrants further study of MD-7246 as a novel treatment for abdominal pain, regardless of IBS subtype.
- |||| Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
Trial completion, Trial completion date, Trial primary completion date: A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome (clinicaltrials.gov) - May 27, 2020
P2, N=388, Completed, Sponsor: Ironwood Pharmaceuticals, Inc.
Persistent, modest abdominal pain improvement with limited impact on bowel symptom parameters, as seen across MD-7246 doses, warrants further study of MD-7246 as a novel treatment for abdominal pain, regardless of IBS subtype. Active, not recruiting --> Completed | Trial completion date: Sep 2020 --> Mar 2020 | Trial primary completion date: Sep 2020 --> Feb 2020
- ||| Linzess (linaclotide) / Ironwood Pharma, AbbVie, Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
Enrollment change: Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) (clinicaltrials.gov) - Apr 24, 2020
P2b, N=759, Completed, Sponsor: Ironwood Pharmaceuticals, Inc.
Active, not recruiting --> Completed | Trial completion date: Sep 2020 --> Mar 2020 | Trial primary completion date: Sep 2020 --> Feb 2020 N=532 --> 759
- ||| Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
Enrollment closed: A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome (clinicaltrials.gov) - Jan 8, 2020
P2, N=388, Active, not recruiting, Sponsor: Ironwood Pharmaceuticals, Inc.
N=532 --> 759 Recruiting --> Active, not recruiting
- Linzess (linaclotide) / Allergan, Astellas, Ironwood, Linzess DR (linaclotide DR) / Allergan, Ironwood
MD-7246, a Delayed-Release Formulation of Linaclotide Targeting Visceral Pain Associated With IBS-D, Does Not Impact Bowel Frequency or Stool Consistency in Healthy Volunteers: Results From Phase I Trial (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1726;
Neither LIN nor its active metabolite were detected in plasma after 7 days of oral administration and no intact tablets were discovered in any subject’s stool. The median and interquartile range (IQR) for change from baseline (CFB) in SBM and BSFS were similar and overlapping for placebo and all 3 MD-7246 dose groups (median (IQR) CFB: SBM: -2.6 (-4.6, 2.9), -1.9 (-4.4, -1.4), -1.3 (-2.0, 0.0), and 0.0 (‑7.7, 0.9); BSFS: 0.4 (-0.2, 1.0), 0.2 (-1.0, 0.9), 0.2 (-0.4, 1.0) and 0.4 (-0.3, 1.8) in placebo and low, mid, and high MD-7246 doses, respectively).
- |||| Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
Enrollment open: A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome (clinicaltrials.gov) - May 2, 2019
P2, N=368, Recruiting, Sponsor: Ironwood Pharmaceuticals, Inc.
The median and interquartile range (IQR) for change from baseline (CFB) in SBM and BSFS were similar and overlapping for placebo and all 3 MD-7246 dose groups (median (IQR) CFB: SBM: -2.6 (-4.6, 2.9), -1.9 (-4.4, -1.4), -1.3 (-2.0, 0.0), and 0.0 (‑7.7, 0.9); BSFS: 0.4 (-0.2, 1.0), 0.2 (-1.0, 0.9), 0.2 (-0.4, 1.0) and 0.4 (-0.3, 1.8) in placebo and low, mid, and high MD-7246 doses, respectively). Not yet recruiting --> Recruiting
- ||||| Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
New P2 trial: A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome (clinicaltrials.gov) - Apr 29, 2019
P2, N=368, Not yet recruiting, Sponsor: Ironwood Pharmaceuticals, Inc.
- |||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
Trial completion: Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) (clinicaltrials.gov) - Jan 23, 2017
P2b, N=532, Completed, Sponsor: Ironwood Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- ||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
Enrollment closed, Phase classification: Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) (clinicaltrials.gov) - Jul 27, 2016
P2b, N=532, Active, not recruiting, Sponsor: Ironwood Pharmaceuticals, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Phase classification: P2 --> P2b
- |||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
Enrollment open: Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) (clinicaltrials.gov) - Jan 15, 2016
P2, N=520, Recruiting, Sponsor: Ironwood Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting | Phase classification: P2 --> P2b Not yet recruiting --> Recruiting
- ||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
New P2 trial: Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) (clinicaltrials.gov) - Sep 24, 2015
P2, N=520, Not yet recruiting, Sponsor: Ironwood Pharmaceuticals, Inc.