Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005520-32 | EudraCT Number |
Not provided
Not provided
Not provided
SB-656933 is no longer being developed for ulcerative colitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will involve the use of a new compound, SB-656933. Accumulation of inflammatory white blood cells (mostly polymorphonuclear neutrophils)in the gut (colon) may be contributing to the pathology of ulcerative colitis. It has been shown that SB-656933 reduces polymorphonuclear neutrophils (PMN) accumulation in pre-clinical models of colitis. 99m-Tc-HMPAO scintigraphy is a imaging technique which will be used in this study to observe the effect of SB656933 on the migration of PMN to inflamed tissue.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7 Days Repeat Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-656933 | Drug | 7 days repeat dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS) | Data has been presented for participants since change from Baseline data was not analyzed. For scintigraphy, blood was obtained for radiolabelling. Labelled white cells were then injected for SPECT scintigraphy and scanning began 45 minutes after injection of labelled White blood cells (WBCs). SPECT images of the colon were divided into 5 segments: ascending colon, transverse colon, descending colon, sigmoid, and rectum.T he SPECT segment uptake ratio was expressed as a fraction of bone marrow activity obtained from counts in the lumbar spine. The SPECT segment uptake ratio was converted into a four-point (0 to 3) segmental SPECT severity score where grade 0 was equal to no uptake. Only 3 participants were included before the study was discontinued.It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1. | Baseline (Day -1) and Day 1 and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Amsterdam | 1105 AZ | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 3 participants were enrolled and randomized from 22 January 2009 to 12 December 2009. This study was conducted at Academic Medical Centre, Amsterdam, The Netherlands. The study was early terminated on 17 February 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SB656933 20 Milligram (mg) | Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 milliliter(mL) of tepid water on every morning of Day 1 to 7 of the treatment period. |
| FG001 | SB656933 100 mg | Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SB656933 20 mg | Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period. |
| BG001 | SB656933 100 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS) | Data has been presented for participants since change from Baseline data was not analyzed. For scintigraphy, blood was obtained for radiolabelling. Labelled white cells were then injected for SPECT scintigraphy and scanning began 45 minutes after injection of labelled White blood cells (WBCs). SPECT images of the colon were divided into 5 segments: ascending colon, transverse colon, descending colon, sigmoid, and rectum.T he SPECT segment uptake ratio was expressed as a fraction of bone marrow activity obtained from counts in the lumbar spine. The SPECT segment uptake ratio was converted into a four-point (0 to 3) segmental SPECT severity score where grade 0 was equal to no uptake. Only 3 participants were included before the study was discontinued.It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1. | The 'All Subjects population' was defined as all participants who received at least one dose of study medication. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Score on scale | Baseline (Day -1) and Day 1 and 7 |
Data for AE was collected up to follow-up (Visit 5) 7 to 10 days after last dose.
The 'All Subjects population' was defined as all participants who received at least one dose of study medication. This population was used for the reporting of AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SB656933 20 mg | Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensation of brick in stomach | Gastrointestinal disorders | MedDRA | Systematic Assessment |
This study was early terminated on 17 February 2010 because investigational drug and further that the duration of treatment (7 days) was unlikely to provide any clinical benefit to participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C568923 | SB 656933 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to follow-up (7 to 10 days after last dose) |
| Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Vital sign measurements included SBP and DBP at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. | Day 1 and 7 |
| Vital Signs Assessment- Heart Rate | Vital sign measurements included heart rate at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. | Day 1 and 7 |
| Changes From Baseline to After Treatment in Faecal Calprotectin Levels | Stool sample was collected from 1-hour post dose until 8 hours post dose for faecal calprotectin measures. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1. | Day -1 and pre-dose and 8 hour post-dose on Day 1 and 7 |
| Amount of Medicine in Blood | Blood samples were collected at 1, 2.25, 4, 8 hour on Day 1 and 7 for the analysis of amount of medicine in blood. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. | At 1, 2.25, 4, 8 hour on Day 1 and 7 |
Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. | All subject population. | Posted | Count of Participants | Participants | Up to follow-up (7 to 10 days after last dose) |
|
|
|
| Secondary | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Vital sign measurements included SBP and DBP at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. | All subject population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | millimeter of mercury (mmHg) | Day 1 and 7 |
|
|
|
| Secondary | Vital Signs Assessment- Heart Rate | Vital sign measurements included heart rate at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. | All subjects population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | beats per minute (bpm) | Day 1 and 7 |
|
|
|
| Secondary | Changes From Baseline to After Treatment in Faecal Calprotectin Levels | Stool sample was collected from 1-hour post dose until 8 hours post dose for faecal calprotectin measures. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1. | All subjects population. | Posted | Number | milligram per litre (mg/L) | Day -1 and pre-dose and 8 hour post-dose on Day 1 and 7 |
|
|
|
| Secondary | Amount of Medicine in Blood | Blood samples were collected at 1, 2.25, 4, 8 hour on Day 1 and 7 for the analysis of amount of medicine in blood. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. | All subjects population. | Posted | Number | nanogram per hour (ng/hr) | At 1, 2.25, 4, 8 hour on Day 1 and 7 |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | SB656933 100 mg | Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period. | 0 | 2 | 0 | 2 | 1 | 2 |
| herpes simplex | Infections and infestations | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| DB: 99001, Day 1, 1 hour |
|
|
| DB: 99001, Day 1, 4 hour |
|
|
| DB: 99001, Day 1, 8 hour |
|
|
| DB: 99001, Day 7, pre-dose |
|
|
| DB: 99001, Day 7, 1 hour |
|
|
| DB: 99001, Day 7, 4 hour |
|
|
| DB: 99001, Day 7, 8 hour |
|
|
| SB: 99001, Day 1, pre-dose |
|
|
| SB: 99001, Day 1, 1 hour |
|
|
| SB: 99001, Day 1, 4 hour |
|
|
| SB: 99001, Day 1, 8 hour |
|
|
| SB: 99001, Day 7, pre-dose |
|
|
| SB: 99001, Day 7, 1 hour |
|
|
| SB: 99001, Day 7, 4 hour |
|
|
| SB: 99001, Day 7, 8 hour |
|
|
| DB: 99003, Day 1, pre-dose |
|
|
| DB: 99003, Day 1, 1 hour |
|
|
| DB: 99003, Day 1, 4 hour |
|
|
| DB: 99003, Day 1, 8 hour |
|
|
| DB: 99003, Day 7, pre-dose |
|
|
| DB: 99003, Day 7, 1 hour |
|
|
| DB: 99003, Day 7, 4 hour |
|
|
| DB: 99003, Day 7, 8 hour |
|
|
| SB: 99003, Day 1, pre-dose |
|
|
| SB: 99003, Day 1, 1 hour |
|
|
| SB: 99003, Day 1, 4 hour |
|
|
| SB: 99003, Day 1, 8 hour |
|
|
| SB: 99003, Day 7, pre-dose |
|
|
| SB: 99003, Day 7, 1 hour |
|
|
| SB: 99003, Day 7, 4 hour |
|
|
| SB: 99003, Day 7, 8 hour |
|
|
| DB: 99002, Day 1, pre-dose |
|
|
| DB: 99002, Day 1, 1 hour |
|
|
| DB: 99002, Day 1, 4 hour |
|
|
| DB: 99002, Day 1, 8 hour |
|
|
| DB: 99002, Day 7, pre-dose |
|
|
| DB: 99002, Day 7, 1 hour |
|
|
| DB: 99002, Day 7, 4 hour |
|
|
| DB: 99002, Day 7, 8 hour |
|
|
| SB: 99002, Day 1, pre-dose |
|
|
| SB: 99002, Day 1, 1 hour |
|
|
| SB: 99002, Day 1, 4 hour |
|
|
| SB: 99002, Day 1, 8 hour |
|
|
| SB: 99002, Day 7, pre-dose |
|
|
| SB: 99002, Day 7, 1 hour |
|
|
| SB: 99002, Day 7, 4 hour |
|
|
| SB: 99002, Day 7, 8 hour |
|
|
| heart rate: 99001, Day 1, 1 hour |
|
|
| heart rate: 99001, Day 1, 4 hour |
|
|
| heart rate: 99001, Day 1, 8 hour |
|
|
| heart rate: 99001, Day 7, pre-dose |
|
|
| heart rate: 99001, Day 7, 1 hour |
|
|
| heart rate: 99001, Day 7, 4 hour |
|
|
| heart rate: 99001, Day 7, 8 hour |
|
|
| heart rate: 99003, Day 1, pre-dose |
|
|
| heart rate: 99003, Day 1, 1 hour |
|
|
| heart rate: 99003, Day 1, 4 hour |
|
|
| heart rate: 99003, Day 1, 8 hour |
|
|
| heart rate: 99003, Day 7, pre-dose |
|
|
| heart rate: 99003, Day 7, 1 hour |
|
|
| heart rate: 99003, Day 7, 4 hour |
|
|
| heart rate: 99003, Day 7, 8 hour |
|
|
| heart rate: 99002, Day 1, pre-dose |
|
|
| heart rate: 99002, Day 1, 1 hour |
|
|
| heart rate: 99002, Day 1, 4 hour |
|
|
| heart rate: 99002, Day 1, 8 hour |
|
|
| heart rate: 99002, Day 7, pre-dose |
|
|
| heart rate: 99002, Day 7, 1 hour |
|
|
| heart rate: 99002, Day 7, 4 hour |
|
|
| heart rate: 99002, Day 7, 8 hour |
|
|
| 99002, Day1 post dose (8 hour) |
|
|
| 99002, Day 7 pre-dose |
|
|
| 99002, Day 7 post dose (8 hour) |
|
|
| 99003, Day1 pre-dose |
|
|
| 99003, Day1 post dose (8 hour) |
|
|
| 99003, Day 7 pre-dose |
|
|
| 99001, Day1 pre-dose |
|
|
| 99001, Day1 post dose (8 hour) |
|
|
| 99001, Day 7 pre-dose |
|
|
| 99001, Day 1, 2.25 hour |
|
|
| 99001, Day 1, 4 hour |
|
|
| 99001, Day 1, 8 hour |
|
|
| 99001, Day 7, 1 hour |
|
|
| 99001, Day 7, 2.25 hour |
|
|
| 99001, Day 7, 4 hour |
|
|
| 99001, Day 7, 8 hour |
|
|
| 99003, Day 1, 1 hour |
|
|
| 99003, Day 1, 2.25 hour |
|
|
| 99003, Day 1, 4 hour |
|
|
| 99003, Day 1, 8 hour |
|
|
| 99003, Day 7, 1 hour |
|
|
| 99003, Day 7, 2.25 hour |
|
|
| 99003, Day 7, 4 hour |
|
|
| 99003, Day 7, 8 hour |
|
|
| 99002, Day 1, 1 hour |
|
|
| 99002, Day 1, 2.25 hour |
|
|
| 99002, Day 1, 4 hour |
|
|
| 99002, Day 1, 8 hour |
|
|
| 99002, Day 7, 1 hour |
|
|
| 99002, Day 7, 2.25 hour |
|
|
| 99002, Day 7, 4 hour |
|
|
| 99002, Day 7, 8 hour |
|
|