The objectives of this study are to assess the safety and efficacy of long-term treatment (2 years) with ABT-229 on postprandial digestive symptoms in patients with functional dyspepsia. Patients will be required to refrain from the use of other prokinetic and anti-secretory agents during the study. The study will consist of follow up visits at one month and every 3 months after the start of treatment for up to 2 years. At each visit, patients will have laboratory tests, pregnancy tests (for females of child bearing potential), pharmacokinetic plasma samples, electrocardiograms, and physical examinations including vital signs. In addition patients will be asked to 1) complete a symptom questionnaire at all visits 2) keep a daily diary and 3) report physician office visits, ER visits, or hospital visits, since the previous study visit. Every 6 months, patients will be asked to compelte the NDI Qualify of Life questionnaire and the 13C-Octanoic acid breath test (13C-OBT) procedures will be performed on the GCRC at the Month 1 Visit and at the Month 6,12,18, and 24 Visits. The GCRC dietary staff will prepare the standarized meal. Six patients have been enrolled to date but none have completed this study.

Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
37
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Case Western Reserve University
Department
Type
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie et al. (2018) Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis. J Perinat Med 46:926-933
Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Saade, G R; Thom, E A; Grobman, W A et al. (2018) Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm. Ultrasound Obstet Gynecol 52:757-762
Inker, Lesley A; Grams, Morgan E; Levey, Andrew S et al. (2018) Relationship of Estimated GFR and Albuminuria to Concurrent Laboratory Abnormalities: An Individual Participant Data Meta-analysis in a Global Consortium. Am J Kidney Dis :
Juraschek, Stephen P; Miller 3rd, Edgar R; Appel, Lawrence J (2018) Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens 31:665-671
Juraschek, Stephen P; Appel, Lawrence J; Miller 3rd, Edgar R (2017) Metoprolol Increases Uric Acid and Risk of Gout in African Americans With Chronic Kidney Disease Attributed to Hypertension. Am J Hypertens 30:871-875
O'Toole, John F; Bruggeman, Leslie A; Madhavan, Sethu et al. (2017) The Cell Biology of APOL1. Semin Nephrol 37:538-545
Chen, Teresa K; Tin, Adrienne; Peralta, Carmen A et al. (2017) APOL1 Risk Variants, Incident Proteinuria, and Subsequent eGFR Decline in Blacks with Hypertension-Attributed CKD. Clin J Am Soc Nephrol 12:1771-1777
Catalano, Patrick M; Shankar, Kartik (2017) Obesity and pregnancy: mechanisms of short term and long term adverse consequences for mother and child. BMJ 356:j1

Showing the most recent 10 out of 753 publications