HemorrhoidsPhase 3NCT00744848
Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
A Phase 3 study testing Bupivacaine HCl and SKY0402 in people with Hemorrhoids, run by Pacira Pharmaceuticals, Inc at 20 sites in United States.
Trial summary
Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Bupivacaine HCl and SKY0402
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 20 sitesUnited States
- Study dates
- Aug 2008to Feb 2009
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female equal or greater than 18 years of age at Screening
- Female subjects: postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery, nonheterosexual lifestyle, or strictly monogamous relationship with a partner who has had a vasectomy.
- Scheduled to undergo 2-or3-column excisional hemorrhoidectomy
- American Society of Anesthesiology (ASA) Physical Class 1-4
- Able and willing to complete with all study visits and procedures
- Able to speak, read, and understand the language of all study forms and instruments used for collecting subject-reported outcomes to provide accurate study assessments
- Willing and capable of provide written informed consent.
Who cannot join
- Pregnant, nursing or planning to become pregnant during the study period
- Use of any long-acting opioid medication within 3 days of surgery or any opioid medication with 24 hours of surgery.
- Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain not strictly related to the procedure or that may interfere with study assessments.
- Single-column hemorrhoidectomy
- Body weight less than 50 kg (110 pounds)
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, or any ingredient of the medications administered in this study (e.g., sulfites in Marcaine with epinephrine)
Show all 14Show fewer
- contraindication to epinephrine
- contraindication to any of the pain-control agents planned for postoperative use
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration
- History of, known addiction, or abuse of illicit drugs, prescription medicines or alcohol within the past 2 years.
- Uncontrolled anxiety schizophrenic, or other psychiatric disorder that may interfere with study assessments or compliance.
- Significant medical conditions or laboratory results that indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial.
- Any clinically significant event or condition uncovered during surgery
- A cumulative incision length less than 3 cm
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Research Concepts, Ltd
Bellaire, Texas, 77401
West Alabama Research Inc.
Birmingham, Alabama, 35209
Univ. Hospitals of Cleveland, Case Medical Center
Cleveland, Ohio, 44106
Duke University Medical Center
Durham, North Carolina, 27710
CTMG, Inc. - Pitt Medical Center
Greenville, North Carolina, 27834
Medical Center Ambulatory Surgery Center
Houston, Texas, 77054
The Women's Hospital of Texas
Houston, Texas, 77054
Indiana University - Wishard Memorial Hospital
Indianapolis, Indiana, 46202
Holston Medical Group
Kingsport, Tennessee, 37660
University of Louisville
Louisville, Kentucky, 40202
Drug Research and Analysis Corporation
Montgomery, Alabama, 36106
Mount Sinai Hospital
New York, New York, 10029
Colon and Rectal Disease Center
Orlando, Florida, 32804
Lotus Clinical Research - Huntington Memorial Hospital
Pasadena, California, 91105
Roland Saenz
San Antonio, Texas, 78205
Accurate Clinical Trials
San Clemente, California, 92672
UCSD Medical Center
San Diego, California, 92121
University of Illinois
Springfield, Illinois, 62708-0787
Multicare Health System
Tacoma, Washington, 98405
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Phase 3, Multicenter, Randomized, Double-Blind, Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
Read the detailed description
Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
- Conditions
- Hemorrhoids
- Being tested
- Bupivacaine HCl, SKY0402
- Keywords
- hemorrhoids
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HClDrug
Also called Marcaine with epinephrine 1:200,000
100 mg Bupivacaine HCl
SKY0402Drug
Also called DepoBupivacaine
Single administration 300 mg SKY0402 in a 40-mL injection volume
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine HCl | Active comparator | 100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration. Receives: Drug: Bupivacaine HCl |
| SKY0402 | Other | 300 mg SKY0402 in a 40-mL injection volume.
A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration. Receives: Drug: SKY0402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores
To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?"
Measured: through 96 hours
Secondary outcomes (1)
Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30
Measured: through day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2009
- Study completionFeb 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kay Warnott, RN, ACN-P, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744848
- Sponsor's protocol ID
- SIMPLE Hemorrhoidectomy 312
- Status last verified
- Jul 2013
- First submitted
- 28 Aug 2008
- Last updated
- 6 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
PubMed 22900785
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multicenter, Randomized, Double-Blind, Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT00744848
- Acronym / sponsor ID
- SIMPLE Hemorrhoidectomy 312
- Conditions
- Hemorrhoids
- Keywords
- hemorrhoids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 1 Sep 2008 (estimated)
- Results
- Posted 6 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
Detailed description
Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine HCl | Active comparator | Drug: Bupivacaine HCl100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration. |
| SKY0402 | Other | Drug: SKY0402300 mg SKY0402 in a 40-mL injection volume. A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female equal or greater than 18 years of age at Screening
- Female subjects: postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery, nonheterosexual lifestyle, or strictly monogamous relationship with a partner who has had a vasectomy.
- Scheduled to undergo 2-or3-column excisional hemorrhoidectomy
- American Society of Anesthesiology (ASA) Physical Class 1-4
- Able and willing to complete with all study visits and procedures
Key exclusion criteria (14 listed)
- Pregnant, nursing or planning to become pregnant during the study period
- Use of any long-acting opioid medication within 3 days of surgery or any opioid medication with 24 hours of surgery.
- Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain not strictly related to the procedure or that may interfere with study assessments.
- Single-column hemorrhoidectomy
- Body weight less than 50 kg (110 pounds)
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 HClAlso: Marcaine with epinephrine 1:200,000100 mg Bupivacaine HCl | Drug | Bupivacaine HCl |
| SKY0402Also: DepoBupivacaineSingle administration 300 mg SKY0402 in a 40-mL injection volume | Drug | SKY0402 |
Primary outcome
Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores
Time frame: through 96 hours
To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?"
1 secondary outcome
Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30
Time frame: through day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22900785Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
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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.
Kay Warnott, RN, ACN-P study director
Pacira Pharmaceuticals, Inc
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine HCl and SKY0402 in people with Hemorrhoids, run by Pacira Pharmaceuticals, Inc at 20 sites 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 7 inclusion and 14 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: finished, as of the sponsor's last update on 6 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 Aug 2013). 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?
Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores (time frame: through 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00744848, which also lists 1 linked publication.
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 6 Aug 2013.