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A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diclofenac potassium (XP21L) | Drug | 25 mg capsule, every 6 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy | Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain | Over 48 hours after bunionectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Perceptible Pain Relief on Day 1 | Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method. | 8 hours post single dose |
| Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Austin | Texas | 78705 | United States | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22587481 | Derived | Daniels SE, Riff D, Diamond E, Clark F, Boesing SE. An assessment of the efficacy and safety of diclofenac potassium liquid-filled capsules in patients with various levels of baseline pain intensity. Curr Med Res Opin. 2012 Jun;28(6):953-61. doi: 10.1185/03007995.2012.694363. Epub 2012 Jun 11. | |
| 20804444 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zipsor (Diclofenac Potassium) Liquid Filled Capsule | 25 mg capsule, every 6 hours |
| FG001 | Placebo | Oral placebo capsule, every 6 hours |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Oral placebo capsule, every 6 hours |
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| 8 hours post single dose |
| Number of Patients With Meaningful Pain Relief on Day 1 | Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method. | 8 hours post single dose |
| Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1 | 8 hours post single dose |
| Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug | Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score. | 8 hourse post single dose |
| Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug | 8 hours post single dose |
| Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug | 8 hours post single dose |
| Number of Patients Who Required Rescue Medication on Day 1 | Day 1 |
| Number of Patients Who Required Rescue Medication on Day 2 | Day 2 |
| Number of Patients Who Required Rescue Medication on Day 3 | Day 3 data reflect the use of rescue medication only up to the time of discharge. | Day 3 |
| Houston |
| Texas |
| 77057 |
| United States |
| Investigative Site | San Marcos | Texas | 78666 | United States |
| Investigative Site | Salt Lake City | Utah | 84117 | United States |
| Daniels SE, Baum DR, Clark F, Golf MH, McDonnell ME, Boesing SE. Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain. Curr Med Res Opin. 2010 Oct;26(10):2375-84. doi: 10.1185/03007995.2010.515478. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zipsor (Diclofenac Potassium) Liquid Filled Capsule | 25 mg capsule, every 6 hours |
| BG001 | Placebo | Oral placebo capsule, every 6 hours |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Baseline Pain Score | Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain | Mean | Standard Deviation | units on a scale |
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| 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 | Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy | Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain | Posted | Mean | Standard Deviation | units on a scale | Over 48 hours after bunionectomy |
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| Secondary | Number of Patients With Perceptible Pain Relief on Day 1 | Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method. | Posted | Number | participants | 8 hours post single dose |
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| Secondary | Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1 | Number of participants analyzed includes only the number of participants with perceptible pain relief on Day 1 (see previous outcome measure #2). | Posted | Median | 95% Confidence Interval | minutes | 8 hours post single dose |
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| Secondary | Number of Patients With Meaningful Pain Relief on Day 1 | Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method. | Posted | Number | participants | 8 hours post single dose |
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| Secondary | Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1 | Number of participants analyzed includes only the number of participants with meaningful pain relief on Day 1 (see previous outcome measure #4). Number of patients in the placebo group is intentionally blank as the data (eg., median and upper CI) were not calculable (see post-hoc outcome measure #12 for available placebo results). | Posted | Median | 95% Confidence Interval | minutes | 8 hours post single dose |
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| Secondary | Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug | Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score. | Posted | Mean | Standard Deviation | units on a scale | 8 hourse post single dose |
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| Secondary | Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug | Posted | Number | participants | 8 hours post single dose |
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| Secondary | Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug | Number of participants analyzed includes only the number of participants with at least 30% reduction in pain intensity after first dose of study drug (see previous outcome measure #7). | Posted | Median | 95% Confidence Interval | minutes | 8 hours post single dose |
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| Secondary | Number of Patients Who Required Rescue Medication on Day 1 | Posted | Number | participants | Day 1 |
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| Secondary | Number of Patients Who Required Rescue Medication on Day 2 | Posted | Number | participants | Day 2 |
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| Secondary | Number of Patients Who Required Rescue Medication on Day 3 | Day 3 data reflect the use of rescue medication only up to the time of discharge. | Posted | Number | participants | Day 3 |
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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 | Zipsor (Diclofenac Potassium) Liquid Filled Capsule | 25 mg capsule, every 6 hours | 0 | 99 | 46 | 99 | ||
| EG001 | Placebo | Oral placebo capsule, every 6 hours | 1 | 101 | 63 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Feeling Hot | General disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Nightmare | Psychiatric disorders | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus generalized | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Boesing | Xanodyne Pharmaceuticals, Inc. | 1-877-926-6396 | clinical-trials@xanodyne.com |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Male |
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| Black |
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| Asian |
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| Hispanic |
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| Other |
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