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| Name | Class |
|---|---|
| Premier Research | OTHER |
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This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.
Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.
This study will assess pain intensity after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2, 5x5cm bupivacaine collagen sponges | Experimental | collagen sponges |
|
| 2, Placebo collagen sponges | Placebo Comparator | Placebo collagen sponges |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Collagen Sponge | Drug | Drug: Bupivacaine Collagen Sponge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores. | The primary efficacy variable was SPI defined as area under the curve (AUC) of 100-mm VAS pain intensity scores after aggravated movement (cough) from 1 to 72 hours after surgery. Minimum score is "0". Maximum score is 7200. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. A lower score means a better outcome or less pain reported. | 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours * the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100* the number of hours in that period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Prior | Innocoll | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellaire | Texas | 77401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22792007 | Result | Cusack SL, Jaros M, Kuss M, Minkowitz HS, Winkle P, Hemsen L. Clinical evaluation of XaraColl((R)), a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies. J Pain Res. 2012;5:217-25. doi: 10.2147/JPR.S33453. Epub 2012 Jun 27. |
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medical investigative sites
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| ID | Title | Description |
|---|---|---|
| FG000 | 2, 5x5cm Bupivacaine Collagen Sponges | Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge - Two 5 × 5-cm bupivacaine sponges each containing 75 mg of Type I collagen and 100 mg bupivacaine hydrochloride, |
| FG001 | 2, Placebo Collagen Sponges | Placebo collagen Sponge: Drug: Placebo Collagen Sponge - Two 5 × 5-cm placebo sponges each containing 75 mg of Type I collagen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Randomized subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | 2, 5x5cm Bupivacaine Collagen Sponges | Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge |
| BG001 | 2, Placebo Collagen Sponges | Placebo collagen Sponge: Drug: Placebo Collagen Sponge |
| 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 Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores. | The primary efficacy variable was SPI defined as area under the curve (AUC) of 100-mm VAS pain intensity scores after aggravated movement (cough) from 1 to 72 hours after surgery. Minimum score is "0". Maximum score is 7200. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. A lower score means a better outcome or less pain reported. | Intent-to-treat population | Posted | Mean | Standard Deviation | score on a scale*hour | 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours. |
|
30 days
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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 | 2, 5x5cm Bupivacaine Collagen Sponges | Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management | Innocoll | 484-406-5211 | ctucker@innocoll.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D003094 | Collagen |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo collagen Sponge | Drug | Drug: Placebo Collagen Sponge |
|
|
| 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours. |
| Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours * the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100* the number of hours in that period. | 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours. |
| Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. The lower the sore the better the outcome. Higher score is a worse outcome | 1,2,4,6,8,10,12,24,48 and 72 hours |
| Pain Intensity VAS Scores Over Time at Rest | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. Lower score is better. Higher score means more pain. Time points are summarized independently | 1,2,4,6,8,10,12,24,48 and 72 hours |
| Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) for each timepoint. (timepoints 1,2,4,6,8,10,12,24,48 and 72 hours ) Patients were asked during multiple time points to provide a score on this VAS scale. For 1 to 24 hours the highest score possible would be 800. For 1 to 48 hours the highest score possible would be 900. For 1 to 72 hours the highest score possible would be 1000. A mean Lower score is better. A mean Higher score is a worse outcome. | 1,2,4,6,8,10,12,24,48 and 72 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo collagen Sponge: Drug: Placebo Collagen Sponge |
|
|
| Secondary | Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours * the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100* the number of hours in that period. | Intent-to-Treat Population | Posted | Mean | Standard Deviation | score on a scale*hour | 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours. |
|
|
|
| Secondary | Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours * the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100* the number of hours in that period. | ITT population | Posted | Mean | Standard Deviation | score on a scale*hour | 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours. |
|
|
|
| Secondary | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. The lower the sore the better the outcome. Higher score is a worse outcome | ITT Population | Posted | Mean | Standard Deviation | units on a scale | 1,2,4,6,8,10,12,24,48 and 72 hours |
|
|
|
| Secondary | Pain Intensity VAS Scores Over Time at Rest | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. Lower score is better. Higher score means more pain. Time points are summarized independently | ITT population | Posted | Mean | Standard Deviation | score on a scale | 1,2,4,6,8,10,12,24,48 and 72 hours |
|
|
|
| Secondary | Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) for each timepoint. (timepoints 1,2,4,6,8,10,12,24,48 and 72 hours ) Patients were asked during multiple time points to provide a score on this VAS scale. For 1 to 24 hours the highest score possible would be 800. For 1 to 48 hours the highest score possible would be 900. For 1 to 72 hours the highest score possible would be 1000. A mean Lower score is better. A mean Higher score is a worse outcome. | ITT population | Posted | Mean | Standard Deviation | score on a scale | 1,2,4,6,8,10,12,24,48 and 72 hours |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 15 |
| 25 |
| EG001 | 2, Placebo Collagen Sponges | Placebo collagen Sponge: Drug: Placebo Collagen Sponge | 0 | 25 | 0 | 25 | 17 | 25 |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Incision site infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | both were mild |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Scrotal swelling | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D000588 |
| Amines |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| 1 to 48 hours |
|
| 49 to 72 hours |
|
| 1 to 48 hours |
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| 49 to 72 hours |
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| 1 to 72 hours |
|
| Hour 4 |
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| Hour 6 |
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| Hour 8 |
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| Hour 10 |
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| Hour 12 |
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| Hour 24 |
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| Hour 48 |
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| Hour 72 |
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| Hour 4 |
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| Hour 6 |
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| Hour 8 |
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| Hour 10 |
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| Hour 12 |
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| Hour 24 |
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| Hour 48 |
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| Hour 72 |
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| 1 to 72 hours |
|