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Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%
The purpose of this randomized, double-blind study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Arm | Experimental | S-Ibuprofen Topical Gel 5% |
|
| Placebo Arm | Placebo Comparator | Vehicle Topical Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-Ibuprofen | Drug | Topical Gel 5% |
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of the Time-weighted Differences From Baseline in Pain Intensity With Movement(SPIDMOVE) Over 24 Hours Post Time Zero | The primary efficacy outcome is the sum of the time-weighted differences from baseline in muscle pain/soreness with movement over 0-24 hours post T0 (SPIDMOVE 0-24h), that is the area under the differences from baseline pain/soreness intensity difference curve. The pain intensity differences (PIDs) with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 pain score with movement from the pain score with movement at time point Ti. Positive and higher scores indicate greater reduction in pain. Measured by Pain Intensity Numerical Rating Scale (PI-NRS) where 0 = no pain and 10 = worst possible pain at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of investigational product (IP). | 0-24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| SPIDMOVE Over the Following Intervals: 0-6, 6-12, 0-12, 12-24, 24-36, 24-48, 0-36, 36-48 and 0-48 Hours Post-T0. | Sum of the time-weighted differences from baseline in pain intensity with movement (SPIDMOVE) over the following intervals: 0-6, 6-12, 0-12, 12-24, 24-36, 0-36, 24-28, 36-48, and 0-48 hours post-T0, that is the area under the differences from baseline pain/soreness intensity difference curve. The PIDs with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 pain score with movement from the pain score with movement at time point Ti. Positive and higher scores indicate greater reduction in pain. Measured by Pain Intensity Numerical Rating Scale (PI-NRS) where 0 = no pain and 10 = worst possible pain at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of IP. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Bertoch, MD | JBR Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
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A total of 434 subjects were screened in the study of which 251 subjects were randomized.
This was a Phase 2/3, single-center study conducted in USA
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Arm | S-Ibuprofen Topical Gel 5% AP0302 (S-ibuprofen topical gel 5%)applied up to 7 times in 24 hours, over a 48-hour dosing period. |
| FG001 | Placebo Arm | Vehicle Topical Gel Placebo topical gel 5% applied up to 7 times in 24 hours, over a 48-hour dosing period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Arm | S-Ibuprofen Topical Gel 5% S-Ibuprofen: Topical Gel 5% |
| BG001 | Placebo Arm | Vehicle Topical Gel Vehicle: Vehicle Gel |
| 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 | Sum of the Time-weighted Differences From Baseline in Pain Intensity With Movement(SPIDMOVE) Over 24 Hours Post Time Zero | The primary efficacy outcome is the sum of the time-weighted differences from baseline in muscle pain/soreness with movement over 0-24 hours post T0 (SPIDMOVE 0-24h), that is the area under the differences from baseline pain/soreness intensity difference curve. The pain intensity differences (PIDs) with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 pain score with movement from the pain score with movement at time point Ti. Positive and higher scores indicate greater reduction in pain. Measured by Pain Intensity Numerical Rating Scale (PI-NRS) where 0 = no pain and 10 = worst possible pain at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of investigational product (IP). | Full Analysis Set: All subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | score on a scale*hours | 0-24 hours. |
Up to Day 7
TEAE was defined as an adverse event that was new or worsened in severity after the first dose of study drug.
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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 | Active Arm | S-Ibuprofen Topical Gel 5% S-Ibuprofen: Topical Gel 5% | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| application site erythema | General disorders | MedDRA (21.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Corroon | Aponia Labs | 917-574-5335 | kcorroon@aponialabs.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2018 | Jun 10, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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active gel and matching vehicle control gel
| Drug |
Vehicle Gel |
|
| From 0-6, 6-12, 0-12, 12-24, 24-36, 0-36, 24-28,36-48, and 0-48 hours post-T0. Time point i included 1, 2, 3, 4, 5, 6 (pre-dose), 7, 8, 9, 10, 11, 12 (pre-dose), 16, 18 (pre-dose), 20, and 24 (pre-dose) hours after the first dose. |
| Sum of Time Weighted Differences From Baseline in Muscle Stiffness (SSID) With Movement Over the Interval | Sum of the time-weighted differences from baseline in muscle stiffness with movement (SSIDMOVE) over the following intervals: 0-6, 6-12, 0-12, 12-24, 0-24, 24-36, 24-48, 0-36, 36-48, and 0-48 hours post-T0, that is the area under the differences from baseline stiffness difference curve. The muscle Stiffness Intensity Differences (SIDs) with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 stiffness score with movement from the stiffness score with movement at time point Ti. Positive and higher scores indicate greater reduction in stiffness. Measured by Muscle Stiffness Numerical Rating Scale (NRS) where 0 = No Stiffness and 10 = Worst Possible Stiffness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of IP. | 0-6, 6-12, 0-12, 12-24, 24-36, 24-48, 0-36, 36-48, and 0-48 post T0 |
| Total Relief With Movement (TOTPAR) 0-6 Hours Post Time Zero | Total relief with movement (TOTPAR) 0-6 hours post time zero TOTPAR was calculated as the sum of pain relief at time point i (PR i) times the weight for each PR i, where i referred to each pain relief scheduled assessment time point between A and B (not including B). The higher the number the better pain relief. Categorical Relief Rating Scale: Subjects rated relief from starting pain with movement using a 5-point categorical relief scale "0=no relief," "1=a little relief," "2=some relief," "3=a lot of relief," or "4=complete relief" at 1, 2, 3, 4, 5, and 6 hours post-initial IP dose and immediately prior to a subsequent dose of IP if one occurred prior to 6 hours. | 0-6 hours |
| Subject Global Assessment of Study Medication Assessed at Approximately 48 Hours Post Time Zero | Global assessment of efficacy will be assessed at approximately 48 hours post-T0 (or upon early termination if the subject withdraws prior to the 48-hour assessment). Subject Global Assessment Using Original 5 Categories as 0=poor, 1=fair, 2=good, 3=very good, 4=excellent. In addition, the 5 categories were dichotomized into 2 categories (good/very good/excellent versus poor/fair). The proportion of good, very good, and excellent ratings were calculated for each treatment. | 48 hours post time zero |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE was defined as an adverse event that was new or worsened in severity after the first dose of study drug. A treatment-related TEAE was defined as a TEAE that was at least possibly related to the administration of study drug or was missing the relationship assessment. If a TEAE was recorded on multiple occasions, only the highest severity was presented. | Up to Day 7 |
| BG002 | Total | Total of all reporting groups |
| 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 (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Active Arm | S-Ibuprofen Topical Gel 5% S-Ibuprofen: Topical Gel 5% |
| OG001 | Placebo Arm | Vehicle Topical Gel Vehicle: Vehicle Gel |
|
|
|
| Secondary | SPIDMOVE Over the Following Intervals: 0-6, 6-12, 0-12, 12-24, 24-36, 24-48, 0-36, 36-48 and 0-48 Hours Post-T0. | Sum of the time-weighted differences from baseline in pain intensity with movement (SPIDMOVE) over the following intervals: 0-6, 6-12, 0-12, 12-24, 24-36, 0-36, 24-28, 36-48, and 0-48 hours post-T0, that is the area under the differences from baseline pain/soreness intensity difference curve. The PIDs with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 pain score with movement from the pain score with movement at time point Ti. Positive and higher scores indicate greater reduction in pain. Measured by Pain Intensity Numerical Rating Scale (PI-NRS) where 0 = no pain and 10 = worst possible pain at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of IP. | Full Analysis Set: All subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | score on a scale*hours | From 0-6, 6-12, 0-12, 12-24, 24-36, 0-36, 24-28,36-48, and 0-48 hours post-T0. Time point i included 1, 2, 3, 4, 5, 6 (pre-dose), 7, 8, 9, 10, 11, 12 (pre-dose), 16, 18 (pre-dose), 20, and 24 (pre-dose) hours after the first dose. |
|
|
|
| Secondary | Sum of Time Weighted Differences From Baseline in Muscle Stiffness (SSID) With Movement Over the Interval | Sum of the time-weighted differences from baseline in muscle stiffness with movement (SSIDMOVE) over the following intervals: 0-6, 6-12, 0-12, 12-24, 0-24, 24-36, 24-48, 0-36, 36-48, and 0-48 hours post-T0, that is the area under the differences from baseline stiffness difference curve. The muscle Stiffness Intensity Differences (SIDs) with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 stiffness score with movement from the stiffness score with movement at time point Ti. Positive and higher scores indicate greater reduction in stiffness. Measured by Muscle Stiffness Numerical Rating Scale (NRS) where 0 = No Stiffness and 10 = Worst Possible Stiffness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of IP. | Full Analysis set: All subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | score on a scale*hours | 0-6, 6-12, 0-12, 12-24, 24-36, 24-48, 0-36, 36-48, and 0-48 post T0 |
|
|
|
| Secondary | Total Relief With Movement (TOTPAR) 0-6 Hours Post Time Zero | Total relief with movement (TOTPAR) 0-6 hours post time zero TOTPAR was calculated as the sum of pain relief at time point i (PR i) times the weight for each PR i, where i referred to each pain relief scheduled assessment time point between A and B (not including B). The higher the number the better pain relief. Categorical Relief Rating Scale: Subjects rated relief from starting pain with movement using a 5-point categorical relief scale "0=no relief," "1=a little relief," "2=some relief," "3=a lot of relief," or "4=complete relief" at 1, 2, 3, 4, 5, and 6 hours post-initial IP dose and immediately prior to a subsequent dose of IP if one occurred prior to 6 hours. | Full Analysis Set: All subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | score on a scale*hours | 0-6 hours |
|
|
|
| Secondary | Subject Global Assessment of Study Medication Assessed at Approximately 48 Hours Post Time Zero | Global assessment of efficacy will be assessed at approximately 48 hours post-T0 (or upon early termination if the subject withdraws prior to the 48-hour assessment). Subject Global Assessment Using Original 5 Categories as 0=poor, 1=fair, 2=good, 3=very good, 4=excellent. In addition, the 5 categories were dichotomized into 2 categories (good/very good/excellent versus poor/fair). The proportion of good, very good, and excellent ratings were calculated for each treatment. | Full Analysis Set: All subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment. | Posted | Count of Participants | Participants | 48 hours post time zero |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE was defined as an adverse event that was new or worsened in severity after the first dose of study drug. A treatment-related TEAE was defined as a TEAE that was at least possibly related to the administration of study drug or was missing the relationship assessment. If a TEAE was recorded on multiple occasions, only the highest severity was presented. | Safety Population: All subjects who received at least 1 dose of study drug. | Posted | Number | participants | Up to Day 7 |
|
|
|
| 126 |
| 0 |
| 126 |
| 123 |
| 126 |
| EG001 | Placebo Arm | Vehicle Topical Gel Vehicle: Vehicle Gel | 0 | 125 | 0 | 125 | 117 | 125 |
| application site induration | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| application site pain | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| application site pruritus | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
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| 0-12 hours |
|
| 12-24 hours |
|
| 24-36 hours |
|
| 24-48 hours |
|
| 0-36 hours |
|
| 36-48 hours |
|
| 0-48 hours |
|
| 0-12 hours |
|
| 12-24 hours |
|
| 0-24 hours |
|
| 24-36 hours |
|
| 24-48 hours |
|
| 0-36 hours |
|
| 36-48 hours |
|
| 0-48 hours |
|
| Original Categories - Good |
|
| Original Categories - Very good |
|
| Original Categories - Excellent |
|
| Dichotomized Categories - Poor/fair |
|
| Dichotomized Categories - Good/very good/excellent |
|
| Subjects with TEAEs leading to discontinuation |
|
| Subjects with SAEs |
|
| TEAE with mild in severity |
|
| TEAE with moderate in severity |
|
| TEAE with Severe in severity |
|