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

NCT02210000 | Completed Phase 2 Results

• 1 other identifier: 201159
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 34

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders Based on the Fullness/Early Satiety Subscale (Responders) as Assessed by Gastrointestinal Cardinal Symptom Index-Daily Diary (GCSI-DD) at Week 12

  The GCSI-DD consists of nine symptom severity items covering the following domains: nausea/vomiting; fullness/early satiety, and bloating. In addition, the GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Participants were asked to rate each symptom on a 6-point scale from 0 to 5 with lower scores representing less symptom severity and higher scores indicating more severe symptoms. Fullness/early satiety response is defined as an improvement from Baseline by at least one point in the weekly average for the subscale. A participant was defined as a responder if the participant's weekly average change from Baseline in the fullness/early satiety response score improved by at least 1 point. Percentage of participants showing response were presented.

  Week 12

Secondary Outcomes (8)

• Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12

  Baseline (Screening) and Week 12

• Number of Participants With Change From Baseline (Day 1) in Blood Pressure of Potential Clinical Importance (PCI) Over 100 Days

  Up to 100 days

• Number of Participants With Change From Baseline (Day 1) in Heart Rate of PCI Over 100 Day

  Up to 100 days

• Number of Participants With Normal and Abnormal 12-lead Electrocardiogram (ECG) Measurements Over 100 Days

  Up to 100 days

• Number of Participants With Change From Baseline in Hematological Abnormalities of PCI by Treatment and Visit Over Period

  Up to 100 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Camicinal 25mg

EXPERIMENTAL

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

Drug: Camicinal

Interventions

Placebo DRUG

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

Placebo

Camicinal DRUG

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

Camicinal 25mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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
• Concurrent enrollment in any other interventional study/(ies) involving a novel (i.e. unapproved or experimental) chemical or biopharmaceutical entity.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (34)

GSK Investigational Site

Chandler, Arizona, 85224, United States

Location

GSK Investigational Site

Long Beach, California, 90807, United States

Location

GSK Investigational Site

Northridge, California, 91325, United States

Location

GSK Investigational Site

Hialeah, Florida, 33016, United States

Location

GSK Investigational Site

Inverness, Florida, 34452, United States

Location

GSK Investigational Site

Miami, Florida, 33183, United States

Location

GSK Investigational Site

Port Orange, Florida, 32127, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30312, United States

Location

GSK Investigational Site

Marietta, Georgia, 30060, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

Towson, Maryland, 21204, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02114, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Flint, Michigan, 48504, United States

Location

GSK Investigational Site

Wyoming, Michigan, 49519, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89123, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89128, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87108, United States

Location

GSK Investigational Site

Poughkeepsie, New York, 12601, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27403, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44109, United States

Location

GSK Investigational Site

Dayton, Ohio, 45439, United States

Location

GSK Investigational Site

Mentor, Ohio, 44060, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Rapid City, South Dakota, 57702, United States

Location

GSK Investigational Site

Bristol, Tennessee, 37620, United States

Location

GSK Investigational Site

Chattanooga, Tennessee, 37421, United States

Location

GSK Investigational Site

Germantown, Tennessee, 38138, United States

Location

GSK Investigational Site

Arlington, Texas, 76014, United States

Location

GSK Investigational Site

Austin, Texas, 78758, United States

Location

GSK Investigational Site

Spring, Texas, 77379, United States

Location

GSK Investigational Site

Bountiful, Utah, 84010, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Gastroparesis; Diabetes Mellitus, Type 2

Interventions

N-(3-fluorophenyl)-1-((4-(((3S)-3-methyl-1-piperazinyl)methyl)phenyl)acetyl)-4-piperidinamine

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 6, 2014
• Study Start: August 27, 2014
• Primary Completion: August 24, 2015
• Study Completion: August 24, 2015
• Last Updated: December 11, 2017
• Results First Posted: November 1, 2017

Record last verified: 2017-09

Locations

US (34)