Pain, PostoperativePhase 2NCT00661466
Efficacy and Safety of A Collagen Bupivacaine Implant in Patients After Gastrointestinal Surgery
A Phase 2 study testing Bupivacaine Collagen Sponge in people with Pain, Postoperative, run by Innocoll at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine Collagen Sponge
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2008to 10 Feb 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be a man or woman who is ≥ 18 and ≤ 75 years of age.
- Has a body mass index (BMI) > 19 and < 40 kg/m2.
- Has a planned elective surgery that requires a vertical or transverse abdominal incision (including but not limited to abdominal aortic aneurysm repair, cholecystectomy and simple bowel resection) to be performed according to standard surgical technique under general anesthesia.
- Has a risk classification of I, II or III according to the American Society of Anesthesiologists (ASA)
- If female, is nonpregnant (negative pregnancy test at Screening and Day 0 before surgery) and nonlactating.
- If female, is either not of childbearing potential or practicing a defined medically acceptable method of birth control and agrees to continue with the regimen throughout the study.
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- Is free of other physical or mental conditions that, in the opinion of the Investigator, may confound quantification of postoperative pain resulting from the surgery.
- Has the ability and willingness to comply with the study procedures and the use of the pain scales; is deemed capable of operating a PCA device; and is able to communicate meaningfully with the study staff.
- Must voluntarily sign and date an informed consent form (ICF) that is approved by an IRB prior to the conduct of any study specific procedures.
- Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.
Who cannot join
- Has known hypersensitivity to amide local anesthetics, opioids or bovine products, or to inactive ingredients of the test article.
- Has 1 of the following surgical procedures planned: total abdominal hysterectomy, omentectomy or surgical procedure for staging cancer.
- Requires the use of Seprafilm® or other absorbable adhesion barriers for the GI surgery.
- Requires any additional surgical procedures either related or unrelated to the GI surgery during the same hospitalization.
- Is required to receive neuraxial (spinal or epidural) opioid analgesics during the study.
- Has cardiac arrhythmia or atrioventricular (AV) conduction disorders.
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- Concomitantly uses antiarrhythmics (eg, amiodarone), propranolol or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).
- Has used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery but are subject to preoperative restrictions for oral intake.
- Has used aspirin or aspirin containing products within 7 days of surgery. Aspirin at a dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the patient has been on a stable dose regimen for ≥ 30 days prior to Screening.
- Has undergone another major surgery within 3 months of the GI surgery.
- Has known or suspected history of alcohol or drug abuse or misuse within 3 years of Screening or evidence of tolerance or physical dependency on opioid analgesics or sedative hypnotic medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albany Medical Center Hospital
Albany, New York, 12208
About this study
Official title: A Phase II, Randomized, Single-dose, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Pharmacokinetic Profile of the CollaRx Bupivacaine Implant in Patients After Gastrointestinal Surgery
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.
Read the detailed description
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.
- Conditions
- Pain, Postoperative
- Being tested
- Bupivacaine Collagen Sponge, Placebo
- Keywords
- Gastrointestinal surgery, Post operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Collagen SpongeDrug
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bupivacaine Collagen Sponge |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to 24 hours postoperatively
Secondary outcomes (10)
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.
Measured: 0 to 48 hours postoperatively
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through 72 hours post insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study start24 Jul 2008
- Primary completion10 Jan 2009
- Study completion10 Feb 2009
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innocoll
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- David Prior, Study director, Innocoll
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661466
- Sponsor's protocol ID
- INN-CB-004
- Status last verified
- Sep 2020
- First submitted
- 15 Apr 2008
- Last updated
- 3 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Single-dose, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Pharmacokinetic Profile of the CollaRx Bupivacaine Implant in Patients After Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT00661466
- Acronym / sponsor ID
- INN-CB-004
- Conditions
- Pain, Postoperative
- Keywords
- Gastrointestinal surgery, Post operative pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 7 participants (actual)
- Lead sponsor
- InnocollIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 24 Jul 2008
- Primary completion
- 10 Jan 2009 (actual)
- Study completion
- 10 Feb 2009 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Posted 3 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bupivacaine Collagen SpongeEither 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 | Drug: PlaceboEither 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must be a man or woman who is ≥ 18 and ≤ 75 years of age.
- Has a body mass index (BMI) > 19 and < 40 kg/m2.
- Has a planned elective surgery that requires a vertical or transverse abdominal incision (including but not limited to abdominal aortic aneurysm repair, cholecystectomy and simple bowel resection) to be performed according to standard surgical technique under general anesthesia.
- Has a risk classification of I, II or III according to the American Society of Anesthesiologists (ASA)
- If female, is nonpregnant (negative pregnancy test at Screening and Day 0 before surgery) and nonlactating.
Key exclusion criteria (11 listed)
- Has known hypersensitivity to amide local anesthetics, opioids or bovine products, or to inactive ingredients of the test article.
- Has 1 of the following surgical procedures planned: total abdominal hysterectomy, omentectomy or surgical procedure for staging cancer.
- Requires the use of Seprafilm® or other absorbable adhesion barriers for the GI surgery.
- Requires any additional surgical procedures either related or unrelated to the GI surgery during the same hospitalization.
- Is required to receive neuraxial (spinal or epidural) opioid analgesics during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine Collagen Sponge | Drug | 1 |
| Placeboplacebo | Drug | 2 |
Primary outcome
The Total Amount of Opioid Rescue Analgesia Used
Time frame: 0 to 24 hours postoperatively
Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
10 secondary outcomes
The Total Amount of Opioid Rescue Analgesia Used
Time frame: 0 to 48 hours postoperatively
The Total Amount of Opioid Rescue Analgesia Used
Time frame: 0 to 72 hours postoperatively
Pain Intensity Rating on the Visual Analogue Scale (VAS)
Time frame: 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0
Pain Intensity Rating on a 4-point Scale
Time frame: 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
Time frame: 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
Time frame: At 72 hours after time 0
Time to First Use of Opioid Rescue Analgesia
Time frame: actual time from time 0
Pharmacokinetic Parameters
Time frame: 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
Time frame: Through 30 days after surgery
Changes in Vital Sign Measurements
Time frame: Through 72 hours post insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Prior study director
Innocoll
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine Collagen Sponge in people with Pain, Postoperative, run by Innocoll at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Total Amount of Opioid Rescue Analgesia Used (time frame: 0 to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.