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A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment where the same procedure as Treatment-1 and -2 was performed, but without the topical application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal application of 2% CHG | Experimental |
| |
| Groin application of 2% CHG | Experimental |
| |
| Control treatment with no application | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine Gluconate | Drug | 2% CHG |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG. | A total of 12 blood samples were collected (one tube of 6 mL each) at various time points up before and after product application in each study period and analyzed for plasma levels of chlorhexidine. Blood samples were collected at 10, 2 and 0.5 hours prior to each treatment, and 1, 2, 3, 4, 5, 6, 8, and 12 hours following each treatment. | Up to 24 hours after product application |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With of Treatment Emergent Adverse Events. | Number of subjects with treatment related adverse events as assessed by System Organ Class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA). | Up to 24 hours after product application, overall, up to 3 weeks |
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Inclusion Criteria:
Subjects were male or female, aged ≥ 18 and ≤ 60 years (inclusive). The main inclusion criteria were:
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| Name | Affiliation | Role |
|---|---|---|
| James Carlson, Pharm D. | Algorithme Pharma USA LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algorithme Pharma USA LLC | Fargo | North Dakota | 58104 | United States |
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Each of the 12 subjects were scheduled to receive one of each treatment and randomized to what period they would receive each.
12 subjects were enrolled to participate in a 3-period, 3-sequence crossover study design
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| ID | Title | Description |
|---|---|---|
| FG000 | Abdominal Application of 2% CHG | Chlorhexidine Gluconate: 2% CHG |
| FG001 | Groin Application of 2% CHG | Chlorhexidine Gluconate: 2% CHG |
| FG002 | Control Treatment With no Application | No treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
| |||||||||||||
| Period 3 |
|
There were a total number of 12 subjects that started but only 10 subjects completed. Abdomen CHG application was completed on 12 subjects, Groin CHG application was completed on 10 subjects and control treatment was completed on 11 subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All 12 study participants are included |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | >= 18 to <= 60 years of age (inclusive) |
| 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 | Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG. | A total of 12 blood samples were collected (one tube of 6 mL each) at various time points up before and after product application in each study period and analyzed for plasma levels of chlorhexidine. Blood samples were collected at 10, 2 and 0.5 hours prior to each treatment, and 1, 2, 3, 4, 5, 6, 8, and 12 hours following each treatment. | There was no statistical analysis planned on the PK results of this study. Results were reported as is. Study was completed as a 3-period, 3-sequence crossover therefore not all arms were analyzed with same amount of participants due to drop out. | Posted | Count of Participants | Participants | Up to 24 hours after product application |
|
Three weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abdominal Application of 2% CHG | Chlorhexidine Gluconate: 2% CHG | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment | Sore Throat |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Regulatory Affairs Specialist | Medline Industries, Inc. | 8476433515 | aminarcik@medline.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2017 | May 1, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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laboratory-blinded, 3-period, 3-sequence, crossover study
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| NOT COMPLETED |
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (kg/m2) | Mean | Standard Deviation | kg/m^2 |
|
| Weight (kg) | Mean | Standard Deviation | weight in "kg" |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| OG001 | Groin Application of 2% CHG | Chlorhexidine Gluconate: 2% CHG |
| OG002 | Control Treatment With no Application | No treatment |
|
|
| Secondary | Number of Subjects With of Treatment Emergent Adverse Events. | Number of subjects with treatment related adverse events as assessed by System Organ Class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA). | Study was completed as a 3-period, 3-sequence crossover therefore not all arms were analyzed with same amount of participants due to drop out. | Posted | Count of Participants | Participants | Up to 24 hours after product application, overall, up to 3 weeks |
|
|
|
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Groin Application of 2% CHG | Chlorhexidine Gluconate: 2% CHG | 0 | 10 | 0 | 10 | 1 | 10 |
| EG002 | Control Treatment With no Application | No treatment | 0 | 11 | 0 | 11 | 1 | 11 |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment | congestion |
|
| Application site pruritus | General disorders | MedDRA (19.0) | Non-systematic Assessment | itching at application site (right groin) |
|
| Application site pain | General disorders | MedDRA (19.0) | Non-systematic Assessment | Burning at application site (right groin) |
|
| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment | Headache |
|
Written consent must be obtained