Trial · NCT02210000
A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis
NCT02210000, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis. Trials, record NCT02210000. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02210000
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis
- NCT number
- NCT02210000
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 114 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Gastroparesis
- Interventions
- Placebo, Camicinal
- First posted
- 2014-08-06
- Last updated
- 2017-12-11
- Results first posted
- 2017-11-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12 | 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. |
| Secondary | Number of Participants With Change From Baseline (Day 1) in Blood Pressure of Potential Clinical Importance (PCI) Over 100 Days | 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. |
| Secondary | Number of Participants With Change From Baseline (Day 1) in Heart Rate of PCI Over 100 Day | 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. |
| Secondary | Number of Participants With Normal and Abnormal 12-lead Electrocardiogram (ECG) Measurements Over 100 Days | 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. |
| Secondary | Number of Participants With Change From Baseline in Hematological Abnormalities of PCI by Treatment and Visit Over Period | 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). |
| Secondary | Number of Participants With Change From Baseline Clinical Chemistry Abnormalities of PCI by Treatment and Visit Over Period | 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. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), and Adverse Events Leading to Discontinuation of the Study Drug | 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. |
| Secondary | Trough Plasma Concentration of Camicinal on Day 28 and Day 84 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Week 12 | Intent-to-treat (ITT) Population comprised of all randomized participants. | Percentage of responders | NUMBER |
| SECONDARY | Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12 | Baseline (Screening) and Week 12 | ITT Population. Only those participants available at the time of assessment were included in the analysis. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Change From Baseline (Day 1) in Blood Pressure of Potential Clinical Importance (PCI) Over 100 Days | Up to 100 days | Safety Population comprised of participants who received at least one dose of the study drug and were followed-up for at least one post-Baseline safety assessment; however, one participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline (Day 1) in Heart Rate of PCI Over 100 Day | Up to 100 days | Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Normal and Abnormal 12-lead Electrocardiogram (ECG) Measurements Over 100 Days | Up to 100 days | Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in Hematological Abnormalities of PCI by Treatment and Visit Over Period | Up to 100 days | Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline Clinical Chemistry Abnormalities of PCI by Treatment and Visit Over Period | Up to 100 days | Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), and Adverse Events Leading to Discontinuation of the Study Drug | Up to end of follow up (100 days) | Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Trough Plasma Concentration of Camicinal on Day 28 and Day 84 | Day 28 and Day 84 | Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group. | NANOGRAM PER MILLILITER (NG/ML) | MEAN |
Source ClinicalTrials.gov
Results by group186
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | CAMICINAL 25 MG | 26.32 | Percentage of responders | ||
| 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 | PLACEBO | 42.11 | Percentage of responders | ||
| Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12 | CAMICINAL 25 MG | Nausea | -1.250 | Standard Error 0.1714 | Scores on a scale |
| Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12 | PLACEBO | Nausea | -1.460 | Standard Error 0.1765 | Scores on a scale |
| Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12 | CAMICINAL 25 MG | Feeling full after meals | -1.063 | Standard Error 0.2102 | Scores on a scale |
| Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12 | PLACEBO | Feeling full after meals | -1.812 | Standard Error 0.2146 | Scores on a scale |
| Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12 | CAMICINAL 25 MG | Bloating | -1.382 | Standard Error 0.2227 | Scores on a scale |
| Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12 | PLACEBO | Bloating | -1.871 | Standard Error 0.2270 | Scores on a scale |
| Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12 | CAMICINAL 25 MG | Unable to finish normal meal | -0.876 | Standard Error 0.1819 | Scores on a scale |
| Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12 | PLACEBO | Unable to finish normal meal | -1.373 | Standard Error 0.1858 | Scores on a scale |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CAMICINAL 25 MG | 57 | |
| Overall Study | STARTED | PLACEBO | 57 | |
| Overall Study | COMPLETED | CAMICINAL 25 MG | 38 | |
| Overall Study | COMPLETED | PLACEBO | 36 | |
| Overall Study | NOT COMPLETED | CAMICINAL 25 MG | 19 | |
| Overall Study | NOT COMPLETED | PLACEBO | 21 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | CAMICINAL 25 MG | 2 | 58 | |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | PLACEBO | 4 | 56 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | CAMICINAL 25 MG | 0 | 58 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | PLACEBO | 2 | 56 | |
| other | CONSTIPATION | Gastrointestinal disorders | CAMICINAL 25 MG | 1 | 58 | |
| other | CONSTIPATION | Gastrointestinal disorders | PLACEBO | 3 | 56 | |
| other | DIARRHOEA | Gastrointestinal disorders | CAMICINAL 25 MG | 3 | 58 | |
| other | DIARRHOEA | Gastrointestinal disorders | PLACEBO | 4 | 56 | |
| other | FLATULENCE | Gastrointestinal disorders | CAMICINAL 25 MG | 2 | 58 | |
| other | FLATULENCE | Gastrointestinal disorders | PLACEBO | 1 | 56 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CAMICINAL 25 MG | 0 | 58 |
| Total, all-cause mortality | PLACEBO | 0 | 56 |
| Total, other adverse events | CAMICINAL 25 MG | 22 | 58 |
| Total, other adverse events | PLACEBO | 27 | 56 |
| Total, serious adverse events | CAMICINAL 25 MG | 3 | 58 |
| Total, serious adverse events | PLACEBO | 2 | 56 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CAMICINAL 25 MG vs PLACEBO: deaths from any cause | Trial comparisons |
| CAMICINAL 25 MG vs PLACEBO: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02210000
GET https://conductscience.org/api/trials/v1/NCT02210000/results?page=2