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Business decision
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| Name | Class |
|---|---|
| Premier Research | OTHER |
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The purpose of this study is to determine whether the CollaRx Bupivacaine Implant (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after gastrointestinal (GI) surgery.
Gastrointestinal (GI) surgery encompasses a range of surgical procedures that involve abdominal incision. Gastrointestinal surgery may be performed to treat an abdominal aortic aneurysm, ulcerative colitis, Crohn's disease, gallbladder disease, bile duct disease and morbid obesity. Although less invasive laparoscopic procedures are performed when warranted, open abdominal surgery is required for certain indications and for more complicated or advanced cases.
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 for 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 compare the amount of narcotic pain medication required after surgery in patients who receive the CollaRx Bupivacaine implant or a plain collagen sponge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision. |
|
| 2 | Placebo Comparator | Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Collagen Sponge | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The Total Amount of Opioid Rescue Analgesia Used | Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | 0 to 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| The Total Amount of Opioid Rescue Analgesia Used | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | 0 to 48 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
Requires any additional surgical procedures either related or unrelated to the GI surgery during the same hospitalization.
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| Name | Affiliation | Role |
|---|---|---|
| David Prior | Innocoll | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center Hospital | Albany | New York | 12208 | United States |
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Study was terminated due to poor recruitment
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| ID | Title | Description |
|---|---|---|
| FG000 | 5x5-cm Bupivacaine Sponges | Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision. Bupivacaine Collagen Sponge |
| FG001 | 5x5-cm Placebo Sponges | Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision. Placebo: placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 5x5-cm Bupivacaine Sponges | Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision. Bupivacaine Collagen Sponge |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Total Amount of Opioid Rescue Analgesia Used | Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Posted | 0 to 24 hours postoperatively |
|
Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
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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 | 5x5-cm Bupivacaine Sponges | Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision. Bupivacaine Collagen Sponge |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypotension | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 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 |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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placebo |
|
| The Total Amount of Opioid Rescue Analgesia Used |
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. |
| 0 to 72 hours postoperatively |
| Pain Intensity Rating on the Visual Analogue Scale (VAS) | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0 |
| Pain Intensity Rating on a 4-point Scale | Study Terminated Early - Secondary end point not measured - not done | At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively |
| Pain Relief Rating on a 5-point Scale | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | At 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0 |
| Patient Global Evaluation of Study Treatment on a 5-point Scale | Study Terminated Early - Secondary end point not measured - not done | At 72 hours after time 0 |
| Time to First Use of Opioid Rescue Analgesia | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | actual time from time 0 |
| Pharmacokinetic Parameters | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively |
| The Incidence of Treatment-emergent Adverse Events | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Through 30 days after surgery |
| Changes in Vital Sign Measurements | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Through 72 hours post insertion |
| 5x5-cm Placebo Sponges |
Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision. Placebo: placebo |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision. Placebo: placebo |
|
| Secondary | The Total Amount of Opioid Rescue Analgesia Used | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Study Terminated Early - Secondary end point not measured - not done | Posted | 0 to 48 hours postoperatively |
|
|
| Secondary | The Total Amount of Opioid Rescue Analgesia Used | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Posted | 0 to 72 hours postoperatively |
|
|
| Secondary | Pain Intensity Rating on the Visual Analogue Scale (VAS) | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Posted | 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0 |
|
|
| Secondary | Pain Intensity Rating on a 4-point Scale | Study Terminated Early - Secondary end point not measured - not done | Study Terminated Early - Secondary end point not measured - not done | Posted | At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively |
|
|
| Secondary | Pain Relief Rating on a 5-point Scale | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Posted | At 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0 |
|
|
| Secondary | Patient Global Evaluation of Study Treatment on a 5-point Scale | Study Terminated Early - Secondary end point not measured - not done | Study Terminated Early - Secondary end point not measured - not done | Posted | At 72 hours after time 0 |
|
|
| Secondary | Time to First Use of Opioid Rescue Analgesia | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Posted | actual time from time 0 |
|
|
| Secondary | Pharmacokinetic Parameters | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Posted | 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively |
|
|
| Secondary | The Incidence of Treatment-emergent Adverse Events | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Posted | Through 30 days after surgery |
|
|
| Secondary | Changes in Vital Sign Measurements | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed. | Posted | Through 72 hours post insertion |
|
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| 0 |
| 4 |
| 1 |
| 4 |
| 1 |
| 4 |
| EG001 | 5x5-cm Placebo Sponges | Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision. Placebo: placebo | 0 | 3 | 0 | 3 | 2 | 3 |
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Arm Pain -IV Site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Polyuria | Gastrointestinal disorders | Systematic Assessment |
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| Marcaine Sensitivity | Product Issues | Systematic Assessment |
|
| Prolonged QT interval | Cardiac disorders | Systematic Assessment |
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| shivering | General disorders | Systematic Assessment |
|
| elevated temperature | General disorders | Systematic Assessment |
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| surgical wound seroma | Surgical and medical procedures | Systematic Assessment |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |