A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis
|ClinicalTrials.gov Identifier: NCT02210000|
Recruitment Status : Completed
First Posted : August 6, 2014
Results First Posted : November 1, 2017
Last Update Posted : December 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastroparesis||Drug: Placebo Drug: Camicinal||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Effect of 12 Weeks of Once-daily Dosing of the Oral Motilin Receptor Agonist Camicinal, on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis|
|Actual Study Start Date :||August 27, 2014|
|Primary Completion Date :||August 24, 2015|
|Study Completion Date :||August 24, 2015|
Placebo Comparator: Placebo
Subjects will receive camicinal matching placebo orally once daily (QD) from Day 1 to Day 84
Camicinal matching placebo is available as tablet to be taken orally with 100mL of water in the morning
Experimental: Camicinal 25mg
Subjects will receive camicinal 25 mg orally QD from Day 1 to Day 84
Camicinal is available as 25 mg tablet to be taken orally with 100mL of water in the morning
- 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 [ Time Frame: 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.
- Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12 [ Time Frame: Baseline (Screening) and Week 12 ]Items of GCSI-DD for gastroparesis (GP) symptom assessment included: 3-nausea, 4-feeling full after meals, 5-bloating, 6-unable to finish normal meal, 7-retching, 8-vomiting, 9-stomach visibly larger, 10-stomach fullness, 11-loss of appetite, 12-upper abdominal pain, 13-upper abdominal discomfort and 14-overall severity of GP symptoms. Each symptom rated on a 6-point scale from 0 to 5 where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Score of nausea/vomiting subscale was mean of items 3, 7, 8; fullness/early satiety subscale was mean of items 4, 6, 10, 11; bloating subscale was mean of items 5, 9. Total GCSI-DD score was mean of 3 subscales. For all, 0 indicated absence of symptom and higher score indicated greater severity of symptoms. Baseline was defined as weekly average of last 7 daily scores recorded during screening period. Change from Baseline was calculated by subtracting mean score for Baseline from weekly average score of Week 12.
- Number of Participants With Change From Baseline (Day 1) in Blood Pressure of Potential Clinical Importance (PCI) Over 100 Days [ Time Frame: Up to 100 days ]Abnormal values of systolic and diastolic blood pressure were measured. If the value for a participant at a given visit was outside the PCI, the participants were further categorized as per the increase or decrease of systolic blood pressure (SBP) and diastolic blood pressure (DBP) from Baseline by 10, 20 and 40 millimeters of mercury (mm of Hg). Number of participants with absolute (ABS) SBP (>160 mm Hg) and ABS DBP (100 mm Hg) were also analyzed. Change from Baseline (CFB) is the post-Baseline value minus the Baseline value. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post-Baseline CFB values were considered. The categories mentioned for data values indicate the blood pressure ranges of clinical concern.
- Number of Participants With Change From Baseline (Day 1) in Heart Rate of PCI Over 100 Day [ Time Frame: Up to 100 days ]Abnormal values of heart rate over 100 days was analyzed and reported. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post baseline CFB values were considered. The categories mentioned for data values indicate the heart rate ranges of clinical concern.
- Number of Participants With Normal and Abnormal 12-lead Electrocardiogram (ECG) Measurements Over 100 Days [ Time Frame: Up to 100 days ]The 12-lead ECG was analyzed as a measure of safety and tolerability. Number of participants with normal ECG, abnormal clinically significant, and abnormal clinically not significant ECG were reported. PR interval of < 110 and > 220 milliseconds (msec), QRS interval of <75 and > 110 msec, absolute QTc interval of > 450 to ≤ 480 or > 480 to ≤ 500 or >500 msec, and increase from Baseline in QTc of > 30 to ≤ 60 msec or >60 msec was considered as of abnormal.
- Number of Participants With Change From Baseline in Hematological Abnormalities of PCI by Treatment and Visit Over Period [ Time Frame: Up to 100 days ]Hematology analysis was performed at screening (fasted) and during the study at each indicated time point. Participants with abnormalities in changes from Baseline values were recorded. Total absolute neutrophil count (tANC <1.5 Giga per Liter [G/L]), hemoglobin (<25 or >25 G/L), hematocrit (<0.075 or >0.075 %), platelet count (<100 or >500 G/L), lymphocytes low (<0.8 G/L), and white blood cells (WBC <3 G/L or >20G/L) were analyzed for their low (L) or high (H) values. Change from Baseline (CFB) was the post-Baseline value minus then Baseline value. Baseline was defined as last non-missing measurement prior to dosing. One participant was randomized to Placebo arm; however, was included within the Camicinal treatment group as they reported at least one PK trough concentration >53 nano-grams per milliliter (ng/mL).
- Number of Participants With Change From Baseline Clinical Chemistry Abnormalities of PCI by Treatment and Visit Over Period [ Time Frame: Up to 100 days ]Clinical chemistry laboratory analysis was performed at screening (fasted) and during the study at each indicated time point. Albumin low (<30 G/L), calcium low (<2 or >2.75 millimoles per Liter [mmol/L]), creatinine (>44 micromoles per Liter change from baseline), Glucose (<3 or >18 mmol/L), potassium (<3.0 or >5.5 mmol/L), sodium (<130 or >150 mmol/L), and carbon di oxide (CO2) (<18 or >35 mmol/L) were analyzed for their low (L) or high (H) values. Participants with abnormalities in changes from Baseline values were recorded. Change from Baseline is the post-Baseline value minus the Baseline value.
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), and Adverse Events Leading to Discontinuation of the Study Drug [ Time Frame: Up to end of follow up (100 days) ]An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Any AE or SAE that led discontinuation of the study drug either by participant or by investigator was considered as an AE leading to discontinuation of the study drug.
- Trough Plasma Concentration of Camicinal on Day 28 and Day 84 [ Time Frame: Day 28 and Day 84 ]A pre-dose blood sample was collected on Days 28 and 84 for pharmacokinetic analysis. This analysis was applicable only for Camicinal arm and thus, no participants from Placebo arm were analyzed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210000
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210000
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|