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A multicenter, double-blind, randomized, placebo- controlled, parallel study to assess the efficacy of 5- HT4 agonist prucalopride for the treatment of diabetic and idiopathic gastroparesis

Award Number: U01DK074035
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Abstract In the clinical world of diagnosis and treatment options for the spectrum of gastroparesis (GP) symptoms, there are still numerous and challenging needs to understand, while at the same time further investigating the pathophysiology of this entity, which affects > 10 million of patients in the US. GP patients exhibit a range of symptoms which do not always correlate with the objective tests we rely on for diagnosis, as well as for assessing their clinical reactions to pharmacological agents. Our response to the NIDDK Gastroparesis Consortium (U01) under RFA-DK-20-504 has the following aims: 1) A) Continue and complete already approved studies initiated by the GpCRC, which specifically entails enrolling qualified patients to Gastroparesis Registry 3, with all relevant clinical and bio-samples, including also PBMC isolation (peripheral blood mononuclear cells), as well as completing the Buspirone (BESST) clinical trial; B) Continue obtaining gastric antral and pyloric smooth muscle tissue samples at the time of surgeries to further advance our knowledge of pathological basis of gastroparesis (PBG) protocol. C) Investigate Pyloric Sphincter Abnormalities in Patients with Gastroparesis Symptoms (PSAGS) per the EndoFlip assessment protocol. B) Our additional proposals for the GP Registry 4 (GpR4) are: 1) During the routine EGD for GpR4 and possible PSAGS studies, we would like to collect samples of duodenal and gastric microbiota by obtaining brushings of gastric and duodenal mucosa; 2) biopsy antral muscularis propria tissue using Endoscopic Submucosal Dissection (ESD) methodology during upper GI endoscopy . 2) As a new research strategy, we propose to investigate whether microbiota obtained at the time of endoscopy by brushing the mucosa of the stomach and duodenum, will differ in their composition in idiopathic and diabetic GP and control patients. We hypothesize that dysbiosis of the upper GI microbiota may contribute to the delayed gastric emptying and symptoms in GP patients, particularly in the idiopathic subgroup of our cohort. 3) Our clinical trial proposal is to investigate the therapeutic efficacy of a new selective 5-HT4 receptor agonist, Pruclalopride, to improve the symptoms and gastric emptying in idiopathic and diabetic GP patients while at the same time having an excellent safety profile. A multicenter, double blind, randomized, placebo- controlled, parallel study, will be conducted were all GpR4 patients from all centers will be invited to be enroll into 2 parallel 4-week treatment periods with placebo or pruclalopride 2mg QD trial.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $445,800 )
2024	2024	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	130 RICK FRANCIS ST	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	15	7/30/2024	NON-COMPETING CONTINUATION	$384,000
2024	2024	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	130 RICK FRANCIS ST	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	15	8/1/2024	SUPPLEMENT FOR EXPANSION	$61,800
														Subtotal = $445,800

Issue Date FY: 2023 ( Subtotal = $461,800 )
2023	2023	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	14	8/7/2023	NON-COMPETING CONTINUATION	$400,000
2023	2023	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	14	8/9/2023	SUPPLEMENT FOR EXPANSION	$61,800
2023	2022	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	13	4/14/2023	COMPETING CONTINUATION	$145,094
2023	2021	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	12	4/14/2023	SUPPLEMENT FOR EXPANSION	-$133,333
2023	2020	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	12	4/14/2023	NON-COMPETING CONTINUATION	-$11,761
														Subtotal = $461,800

Issue Date FY: 2022 ( Subtotal = $400,000 )
2022	2022	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	13	9/19/2022	COMPETING CONTINUATION	$0
2022	2022	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	13	8/29/2022	COMPETING CONTINUATION	$400,000
2022	2020	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	12	10/25/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $400,000

Issue Date FY: 2021 ( Subtotal = $310,243 )
2021	2021	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	005	12	9/8/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2021	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	12	8/30/2021	SUPPLEMENT FOR EXPANSION	$133,333
2021	2020	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	12	8/25/2021	NON-COMPETING CONTINUATION	$0
2021	2020	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	12	2/19/2021	NON-COMPETING CONTINUATION	$0
2021	2020	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	12	9/8/2021	NON-COMPETING CONTINUATION	$0
2021	2019	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	11	12/2/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$176,910
														Subtotal = $310,243

Issue Date FY: 2020 ( Subtotal = $353,375 )
2020	2020	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	12	8/13/2020	NON-COMPETING CONTINUATION	$382,355
2020	2020	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	12	9/1/2020	SUPPLEMENT FOR EXPANSION	$147,930
2020	2019	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	11	3/25/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2020	2018	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH STREET	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	2/12/2020	NON-COMPETING CONTINUATION	-$176,910
														Subtotal = $353,375

Issue Date FY: 2019 ( Subtotal = $386,809 )
2019	2019	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	11	9/19/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$386,809
2019	2018	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH STREET	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	5/22/2019	NON-COMPETING CONTINUATION	$0
2019	2018	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH STREET	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	10	9/19/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $386,809

Issue Date FY: 2018 ( Subtotal = $374,151 )
2018	2018	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH ST	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	9/12/2018	NON-COMPETING CONTINUATION	$374,151
														Subtotal = $374,151

Issue Date FY: 2017 ( Subtotal = $378,366 )
2017	2017	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH ST MS 6271	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	9	9/1/2017	NON-COMPETING CONTINUATION	$378,366
2017	2016	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH ST MS 6271	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	8	2/17/2017	COMPETING CONTINUATION	$161,824
2017	2016	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH ST MS 6271	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	8	6/15/2017	COMPETING CONTINUATION	$93
2017	2015	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH ST MS 6271	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	7	2/17/2017	NON-COMPETING CONTINUATION	-$161,824
2017	2015	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH ST MS 6271	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	7	6/15/2017	NON-COMPETING CONTINUATION	-$93
														Subtotal = $378,366

Issue Date FY: 2016 ( Subtotal = $382,500 )
2016	2016	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH STREET	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	8	9/23/2016	COMPETING CONTINUATION	$382,500
2016	2015	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH STREET	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	7	9/20/2016	NON-COMPETING CONTINUATION	$0
														Subtotal = $382,500

Issue Date FY: 2015 ( Subtotal = $469,368 )
2015	2015	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH STREET	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	7	9/9/2015	NON-COMPETING CONTINUATION	$469,368
														Subtotal = $469,368

Issue Date FY: 2014 ( Subtotal = $466,313 )
2014	2014	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH STREET	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	6	9/16/2014	NON-COMPETING CONTINUATION	$466,313
														Subtotal = $466,313

Issue Date FY: 2013 ( Subtotal = $386,847 )
2013	2013	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH STREET	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	9/5/2013	NON-COMPETING CONTINUATION	$386,847
														Subtotal = $386,847

Issue Date FY: 2012 ( Subtotal = $258,532 )
2012	2012	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH STREET	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	9/14/2012	NON-COMPETING CONTINUATION	$258,532
														Subtotal = $258,532

Issue Date FY: 2011 ( Subtotal = $415,133 ) (Continued on the next page)
2011	2011	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER	3601 4TH STREET	LUBBOCK	TX	79430	LUBBOCK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	9/1/2011	COMPETING CONTINUATION	$415,133
Grand Total All Awards = $5,872,314

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A multicenter, double-blind, randomized, placebo- controlled, parallel study to assess the efficacy of 5- HT4 agonist prucalopride for the treatment of diabetic and idiopathic gastroparesis

Award Number: U01DK074035

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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