Diabetic Gastroparesis — Study of Promethazine for Treatment of Diabetic Gastroparesis
Citation(s)
Braude D, Crandall C Ondansetron versus promethazine to treat acute undifferentiated nausea in the emergency department: a randomized, double-blind, noninferiority trial. Acad Emerg Med. 2008 Mar;15(3):209-15. doi: 10.1111/j.1553-2712.2008.00060.x.
Cherian D, Parkman HP Nausea and vomiting in diabetic and idiopathic gastroparesis. Neurogastroenterol Motil. 2012 Mar;24(3):217-22, e103. doi: 10.1111/j.1365-2982.2011.01828.x. Epub 2011 Nov 27.
Ehrenpreis ED, Deepak P, Sifuentes H, Devi R, Du H, Leikin JB The metoclopramide black box warning for tardive dyskinesia: effect on clinical practice, adverse event reporting, and prescription drug lawsuits. Am J Gastroenterol. 2013 Jun;108(6):866-72. doi: 10.1038/ajg.2012.300.
Feldman M, Smith HJ Effect of cisapride on gastric emptying of indigestible solids in patients with gastroparesis diabeticorum. A comparison with metoclopramide and placebo. Gastroenterology. 1987 Jan;92(1):171-4.
McHugh S, Lico S, Diamant NE Cisapride vs metoclopramide. An acute study in diabetic gastroparesis. Dig Dis Sci. 1992 Jul;37(7):997-1001.
Patterson D, Abell T, Rothstein R, Koch K, Barnett J A double-blind multicenter comparison of domperidone and metoclopramide in the treatment of diabetic patients with symptoms of gastroparesis. Am J Gastroenterol. 1999 May;94(5):1230-4.
Perkel MS, Moore C, Hersh T, Davidson ED Metoclopramide therapy in patients with delayed gastric emptying: a randomized, double-blind study. Dig Dis Sci. 1979 Sep;24(9):662-6.
Reilly MC, Bracco A, Ricci JF, Santoro J, Stevens T The validity and accuracy of the Work Productivity and Activity Impairment questionnaire--irritable bowel syndrome version (WPAI:IBS). Aliment Pharmacol Ther. 2004 Aug 15;20(4):459-67.
Revicki DA, Camilleri M, Kuo B, Szarka LA, McCormack J, Parkman HP Evaluating symptom outcomes in gastroparesis clinical trials: validity and responsiveness of the Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD). Neurogastroenterol Motil. 2012 May;24(5):456-63, e215-6. doi: 10.1111/j.1365-2982.2012.01879.x. Epub 2012 Jan 27.
Tan PC, Khine PP, Vallikkannu N, Omar SZ Promethazine compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial. Obstet Gynecol. 2010 May;115(5):975-81. doi: 10.1097/AOG.0b013e3181d99290.
Wahlqvist P, Carlsson J, Stålhammar NO, Wiklund I Validity of a Work Productivity and Activity Impairment questionnaire for patients with symptoms of gastro-esophageal reflux disease (WPAI-GERD)--results from a cross-sectional study. Value Health. 2002 Mar-Apr;5(2):106-13.
A Pilot, Randomized, Double-blind, Placebo-controlled Trial of Promethazine for Treatment of Diabetic Gastroparesis.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
