A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis

Inclusion Criteria

• Type 1 or 2 diabetes mellitus (acetylated hemoglobin A1 [HbA1c] upper limit of normal as determined by Carbon-13 radioisotope (C13) oral breath test; % C13-dose recovered =3 month history of relevant symptoms of gastroparesis (e.g., chronic post-prandial fullness, early satiety, post-prandial nausea).
• Patients will have a mean of the daily scores over a minimum of 7 days indicating >= mild (2) severity for the fullness/early satiety subscale as assessed using the GCSI-DD during the screening period prior to randomization.
• A female patient is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] >40 milli international units per milliliter [mIU/mL], or a value consistent with the local laboratory standard value, is confirmatory) or is of child-bearing potential and agrees to use contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female patients must agree to use contraception for at least 5 days following the last dose of study medication.
• Body mass index (BMI) >18 and 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin 6 months previously) and was not being repeated.
• Patient has had a gastrectomy, or major gastric surgical procedure or any evidence of bowel obstruction or strictures within the previous 12 months
• Dosage of any concomitant medications has not been stable for at least 3 weeks, except for routine adjustments in daily insulin treatments.
• Estimated (or measured) glomerular filtration rate <=30 mL/minute.
• Daily opiate use at screening
• Use of prohibited medications that potentially influence upper gastrointestinal motility or appetite, or medications that may interfere with the methods of measuring gastric emptying e.g., prokinetic drugs, macrolide antibiotics (erythromycin, azithromycin), GLP-1 mimetics, anti-cholinergics, chronic/regular use of opiates
• History or presence of clinically significant gastro-intestinal, hepatic or renal disease (including liver disease or known hepatic or biliary abnormalities, with the exception of Gilbert's syndrome or asymptomatic gallstones) or other condition that would in the opinion of the investigator or medical monitor make the subject unsuitable for inclusion in this clinical study.
• Concurrent enrollment in any other interventional study/(ies) involving a novel (i.e. unapproved or experimental) chemical or biopharmaceutical entity.
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline Medical Monitor, contraindicates their participation.
• Lactating or Pregnant females as determined by positive serum or urine human chorionic gonadotropin test (from the first urine of the day) at screening or prior to dosing.
• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening