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

NCT ID: NCT02210000

Last Updated: 2017-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-27
• Study Completion Date: 2015-08-24

Brief Summary

This study is a randomized, double-blind, placebo controlled trial designed to confirm the symptomatic effects of camicinal treatment vs. placebo, on gastroparesis symptoms in type 1 and 2 diabetic subjects with gastroparesis. The primary purpose of this study is to determine if a low-dose of camicinal (25 milligram[mg]) for 12 weeks of repeat administration improves gastroparesis symptoms as measured by the Gastrointestinal Cardinal Symptom Index - Daily Diary (GCSI-DD) in approximately 120 subjects with type 1 or 2 diabetes mellitus (DM) who have documented abnormally slow gastric emptying and have symptoms consistent with gastroparesis.

Subjects will be randomized in a 1:1 ratio to receive either camicinal or placebo. The study will consist of a screening/baseline period of up to 35 days, a 12 week treatment period, a 2-week post-treatment assessment of symptoms and a 14 day (+/- 2 days) post treatment safety follow-up visit.

Conditions

Gastroparesis

Keywords

repeat dose; phase II; GCSI-DD; pharmacodynamics; gastroparesis; type 1 and type 2 diabetes mellitus; camicinal; GSK962040; symptoms; gut motility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Subjects will receive camicinal matching placebo orally once daily (QD) from Day 1 to Day 84

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Camicinal matching placebo is available as tablet to be taken orally with 100mL of water in the morning

Camicinal 25mg

Subjects will receive camicinal 25 mg orally QD from Day 1 to Day 84

Group Type: EXPERIMENTAL

Camicinal

Intervention Type: DRUG

Camicinal is available as 25 mg tablet to be taken orally with 100mL of water in the morning

Interventions

Placebo

Camicinal matching placebo is available as tablet to be taken orally with 100mL of water in the morning

Intervention Type: DRUG

Camicinal

Camicinal is available as 25 mg tablet to be taken orally with 100mL of water in the morning

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Type 1 or 2 diabetes mellitus (acetylated hemoglobin A1 [HbA1c] <=11.0%)
• Male or female between 18 and 80 years of age, inclusive.
• Patient has gastroparesis at screening. A patient is eligible if one of the following criteria are met: Gastric half-time of emptying >upper limit of normal as determined by Carbon-13 radioisotope (C13) oral breath test; % C13-dose recovered < lower limit of normal at 90 or 120 minutes
• Patient must report a >=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 <=42.0 kilogram per meter square (kg/m^2) (inclusive).
• QTc <450 millisecond (msec) or QTc <480 msec in patients with Bundle Branch Block based on single or average QTc value of triplicate values obtained over a brief recording period. The QT correction formula (Bazett's, Fridericia's, etc) used to determine inclusion and discontinuation should be the same throughout the study.
• Aspartate aminotransferase and alanine aminotransferase <2x upper limit of normal (ULN); alkaline phosphatase and bilirubin <=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria

• Patient has acute severe gastroenteritis
• Patient has a gastric pacemaker
• Patient is on chronic enteral (e.g., feeding tube) or parenteral feeding
• Recent (last 6 weeks) history of poor control of diabetes e.g. hypoglycaemia requiring medical intervention, diabetic ketoacidosis, admission for control of diabetes or complications of diabetes
• Patient has evidence of severe cardiovascular autonomic neuropathy (e.g. history of recurrent syncope in the last 6 months)
• Patient has a history of eating disorders (anorexia nervosa, binge eating, bulimia)
• Use of medications potentially influencing upper gastrointestinal motility or appetite at least 1 week prior to screening (e.g., prokinetic drugs, macrolide antibiotics [erythromycin], glucagon-like peptide-1 [GLP-1] mimetics)
• Patient has had intrapyloric botox injections.
• A patient would be eligible if the botox treatment was in the past (>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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Northridge, California, United States

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

Inverness, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Port Orange, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Indianapolis, Indiana, United States

GSK Investigational Site

Towson, Maryland, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Flint, Michigan, United States

GSK Investigational Site

Wyoming, Michigan, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Albuquerque, New Mexico, United States

GSK Investigational Site

Poughkeepsie, New York, United States

GSK Investigational Site

Greensboro, North Carolina, United States

GSK Investigational Site

Winston-Salem, North Carolina, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Dayton, Ohio, United States

GSK Investigational Site

Mentor, Ohio, United States

GSK Investigational Site

Greenville, South Carolina, United States

GSK Investigational Site

Rapid City, South Dakota, United States

GSK Investigational Site

Bristol, Tennessee, United States

GSK Investigational Site

Chattanooga, Tennessee, United States

GSK Investigational Site

Germantown, Tennessee, United States

GSK Investigational Site

Arlington, Texas, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Spring, Texas, United States

GSK Investigational Site

Bountiful, Utah, United States

GSK Investigational Site

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

201159

Identifier Type: -

Identifier Source: org_study_id