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| ID | Type | Description | Link |
|---|---|---|---|
| B4811001 |
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Although approved for minor strains, sprains and contusions, FLECTOR Patch has not been studied extensively in the setting of acute back strain. This study is being conducted as an initial step in demonstrating the benefit of FLECTOR Patch specifically for back strain. In particular, this study is expected to provide information about the amount of improvement in back strain among subjects using the FLECTOR Patch, which may then be used to inform subsequent studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLECTORA Patch (diclofenac epolamine topical patch) 1.3% | Experimental | One patch applied every 12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLECTOR® Patch (diclofenac epolamine topical patch) 1.3% | Drug | One FLECTOR Patch applied to the most painful area on the subject's back every 12 hours for up to 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 5: Please rate your pain by marking the box beside the number that best describes your pain on the average (over the last 24 hours); rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). | Baseline, End of Treatment (last visit up to Day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 1: Have you had pain other than everyday kinds of pain?; response = Yes or No. |
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Inclusion Criteria:
Participants in the study must:
Exclusion Criteria:
Participants may not be in the study if they:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible. |
| 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 | Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 5: Please rate your pain by marking the box beside the number that best describes your pain on the average (over the last 24 hours); rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). | Intent to Treat (ITT) population: had at least one application of FLECTOR® Patch, pain survey data at Baseline, and at least 1 follow-up visit. EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, End of Treatment (last visit up to Day 15) |
|
Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Baseline, End of Treatment (last visit up to Day 15) |
| Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 3: Rate your pain at its worst in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). | Baseline, End of Treatment (last visit up to Day 15) |
| Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 4: Rate your pain at its least in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). | Baseline, End of Treatment (last visit up to Day 15) |
| Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 6: Rate your pain right now; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). | Baseline, End of Treatment (last visit up to Day 15) |
| Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 8: Rate your percent reduction in pain from Baseline (0% = no relief to 100% = complete relief). | Baseline, End of Treatment (last visit up to Day 15) |
| Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant | Global pain relief as assessed by participant using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change. | End of Treatment (up to Day 15) |
| Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator | Participants' global pain relief as assessed by investigator using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change. | End of Treatment (up to Day 15) |
| Mean Change From Baseline to EOT in Beck Depression Inventory® Il | The Beck Depression Inventory® II consisted of 21 items, each with 4 categorical responses ranging from 0 (I do not feel sad) to 3 (I am so sad or unhappy that I can't stand it) with maximum possible score of 63; increase in the number reflected an increase in severity. Total Beck Depression Inventory® II scores classified as follows: 1 to 10=normal ups and downs; 11 to 16=mild mood disturbance; 17 to 20=borderline clinical depression; 21 to 30=moderate depression; 31 to 40=severe depression; and >40=extreme depression. | Baseline, End of Treatment (last visit up to Day 15) |
| Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant | Participant satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied. | End of Treatment (last visit up to Day 15) |
| Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator | Investigator's assessment of participants' satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied. | End of Treatment (last visit up to Day 15) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. |
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible. |
|
|
|
| Secondary | Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 1: Have you had pain other than everyday kinds of pain?; response = Yes or No. | ITT population; EOT score was the last non-missing score obtained on a treatment day, including the final treatment visit. | Posted | Number | participants | Baseline, End of Treatment (last visit up to Day 15) |
|
|
|
|
| Secondary | Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 3: Rate your pain at its worst in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). | ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, End of Treatment (last visit up to Day 15) |
|
|
|
|
| Secondary | Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 4: Rate your pain at its least in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). | ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, End of Treatment (last visit up to Day 15) |
|
|
|
|
| Secondary | Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 6: Rate your pain right now; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). | ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, End of Treatment (last visit up to Day 15) |
|
|
|
|
| Secondary | Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 8: Rate your percent reduction in pain from Baseline (0% = no relief to 100% = complete relief). | ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day. N=number of participants with analyzable data for Question 8 at observation. | Posted | Mean | Standard Deviation | percent | Baseline, End of Treatment (last visit up to Day 15) |
|
|
|
|
| Secondary | Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant | Global pain relief as assessed by participant using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change. | ITT population | Posted | Number | participants | End of Treatment (up to Day 15) |
|
|
|
| Secondary | Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator | Participants' global pain relief as assessed by investigator using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change. | ITT population | Posted | Number | participants | End of Treatment (up to Day 15) |
|
|
|
| Secondary | Mean Change From Baseline to EOT in Beck Depression Inventory® Il | The Beck Depression Inventory® II consisted of 21 items, each with 4 categorical responses ranging from 0 (I do not feel sad) to 3 (I am so sad or unhappy that I can't stand it) with maximum possible score of 63; increase in the number reflected an increase in severity. Total Beck Depression Inventory® II scores classified as follows: 1 to 10=normal ups and downs; 11 to 16=mild mood disturbance; 17 to 20=borderline clinical depression; 21 to 30=moderate depression; 31 to 40=severe depression; and >40=extreme depression. | ITT population; End-of-Treatment score was the most recent non-missing value. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, End of Treatment (last visit up to Day 15) |
|
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|
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| Secondary | Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant | Participant satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied. | ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded. | Posted | Number | participants | End of Treatment (last visit up to Day 15) |
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|
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| Secondary | Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator | Investigator's assessment of participants' satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied. | ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded. | Posted | Number | participants | End of Treatment (last visit up to Day 15) |
|
|
|
| 1 |
| 123 |
| 15 |
| 123 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Application site rash | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Application site pruritus | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Measurements |
|---|---|
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| Change at EOT: Bsl=No, EOT=No |
|
| Title | Measurements |
|---|---|
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| 2=Slight Improvement |
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| 1=No Change |
|
| Title | Measurements |
|---|---|
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| 2=Slight Improvement |
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| 1=No Change |
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| Title | Measurements |
|---|---|
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| 2=Dissatisfied |
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| 1=Very Dissatisfied |
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| Title | Measurements |
|---|---|
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| 2=Dissatisfied |
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| 1=Very Dissatisfied |
|