Postoperative PainPhase 2NCT00993226
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
A Phase 2 study testing SABER-Bupivacaine Treatment 1a, Bupivacaine HCl Treatment 1c and SABER-Bupivacaine Treatment 2a in people with Postoperative Pain, run by Durect at 14 sites in 6 countries.
Trial summary
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- SABER-Bupivacaine Treatment 1a, Bupivacaine HCl Treatment 1c and SABER-Bupivacaine Treatment 2a
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 14 sitesin 6 countries
- Study dates
- May 2009to Jul 2010
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A planned elective, abdominal hysterectomy
- Patients suitable for general anaesthesia
Who cannot join
- Known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities
- Known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances. History of cured localised malignancies is allowed (i.e. basal or squamous cell skin carcinoma, breast carcinoma or cervical carcinoma)
- Abnormal ECG
- Prolonged QT syndrome
- Current or regular use of analgesic medication for other indication(s)
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
Hungary8 sites
Nycomed
Békéscsaba
Nycomed
Budapest
Nycomed
Debrecen
Nycomed
Győr
Nycomed
Nyíregyháza
Nycomed
Székesfehérvár
Nycomed
Szolnok
Nycomed
Tatabánya
About this study
Official title: An International, Randomised, Double Blinded, Multi-centre, Active- and Placebo-controlled Dose Response Trial to Evaluate the Efficacy and Safety of SABER-Bupivacaine for Postoperative Pain Control in Patients Undergoing Primary, Elective, Open, Abdominal Hysterectomy
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on the efficacy and safety of the product.
- Conditions
- Postoperative Pain
- Being tested
- SABER-Bupivacaine Treatment 1a, Placebo SABER-Bupivacaine Treatment 1b, Bupivacaine HCl Treatment 1c, SABER-Bupivacaine Treatment 2a, Placebo SABER-Bupivacaine Treatment 2b
- Keywords
- Postoperative pain, Local anaesthesia, Postoperative pain after open abdominal hysterectomy surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SABER-Bupivacaine Treatment 1aDrug
5.0 ml
Placebo SABER-Bupivacaine Treatment 1bDrug
Also called POSIMIR® bupivacaine solution
5.0 ml
Bupivacaine HCl Treatment 1cDrug
40 ml
SABER-Bupivacaine Treatment 2aDrug
7.5 ml
Placebo SABER-Bupivacaine Treatment 2bDrug
7.5 ml
Bupivacaine HCl Treatment 2cDrug
40 ml
| Study group | Role | What they receive |
|---|---|---|
| SABER-Bupivacaine Treatment 1a | Experimental | double-blind Receives: Drug: SABER-Bupivacaine Treatment 1a |
| Placebo SABER-Bupivacaine Treatment 1b | Placebo comparator | double-blind Receives: Drug: Placebo SABER-Bupivacaine Treatment 1b |
| Bupivacaine HCl Treatment 1c | Active comparator | double-blind Receives: Drug: Bupivacaine HCl Treatment 1c |
| SABER-Bupivacaine Treatment 2a | Experimental | double-blind Receives: Drug: SABER-Bupivacaine Treatment 2a |
| Placebo SABER-Bupivacaine Treatment 2b | Placebo comparator | double-blind Receives: Drug: Placebo SABER-Bupivacaine Treatment 2b |
| Bupivacaine HCl Treatment 2c | Active comparator | double-blind Receives: Drug: Bupivacaine HCl Treatment 2c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (PI)
Pain intensity (PI) on movement AUC over the period 1 to 72 hours post-surgery. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Measured: 1 to 72 hours post-surgery
Supplemental Opioid Use
Cumulative IV morphine-equivalent dose of opioid rescue medication
Measured: 0-3 days after surgery
Secondary outcomes (2)
Time to First Opioid Rescue Medication Usage
Measured: 0-14 days after surgery
Opioid Related Side Effects
Opioid-related side effects were recorded 0-7 days after surgery. The Opioid-Related Symptom Distress Scale (OR-SDS) is a composite score computed from a questionnaire containing frequent opioid-related symptoms (Fatigue, Drowsiness, Inability to concentrate, Nausea, Dizziness, Constipation, Itching, Difficulty with urination, Confusion, Retching/vomiting). For each symptom, patients assigned integer scores to assess severity (none=0 to very severe=4), bothersomeness (none=0 to very much=5), and frequency (none=0 to almost constantly=4); patients reported number of Retching/vomiting episodes (none=0, 1-2 episodes=1, 3-4 episodes=2, 5-6 episodes=3, >6 episodes=4).
On each day (Day 0-7), the score for each symptom was the mean of the three component scores, and the OR-SDS score was the overall mean of the 10 symptom scores, (values from 0 to 4; larger outcomes are worse). The mean of the daily OR-SDS score from Day 0 to 7 gave the overall OR-SDS Score.
Measured: 0-7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2009
- Study completionJul 2010
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 Postoperative PainStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durect
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nycomed
- Responsible party
- Sponsor
- Investigators
- Nycomed Clinical Trial Operations, Study chair, Headquarters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993226
- Sponsor's protocol ID
- BU-001-IM
- Status last verified
- May 2021
- First submitted
- 9 Oct 2009
- Last updated
- 1 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Randomised, Double Blinded, Multi-centre, Active- and Placebo-controlled Dose Response Trial to Evaluate the Efficacy and Safety of SABER-Bupivacaine for Postoperative Pain Control in Patients Undergoing Primary, Elective, Open, Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT00993226
- Acronym / sponsor ID
- BU-001-IM
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Local anaesthesia, Postoperative pain after open abdominal hysterectomy surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- DurectIndustry (pharma, biotech, devices)
- Collaborators
- Nycomed
- Study start
- May 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Oct 2009 (estimated)
- Results
- Posted 1 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on the efficacy and safety of the product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SABER-Bupivacaine Treatment 1a | Experimental | Drug: SABER-Bupivacaine Treatment 1adouble-blind |
| Placebo SABER-Bupivacaine Treatment 1b | Placebo comparator | Drug: Placebo SABER-Bupivacaine Treatment 1bdouble-blind |
| Bupivacaine HCl Treatment 1c | Active comparator | Drug: Bupivacaine HCl Treatment 1cdouble-blind |
| SABER-Bupivacaine Treatment 2a | Experimental | Drug: SABER-Bupivacaine Treatment 2adouble-blind |
| Placebo SABER-Bupivacaine Treatment 2b | Placebo comparator | Drug: Placebo SABER-Bupivacaine Treatment 2bdouble-blind |
| Bupivacaine HCl Treatment 2c | Active comparator | Drug: Bupivacaine HCl Treatment 2cdouble-blind |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A planned elective, abdominal hysterectomy
- Patients suitable for general anaesthesia
Key exclusion criteria (5 listed)
- Known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities
- Known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances. History of cured localised malignancies is allowed (i.e. basal or squamous cell skin carcinoma, breast carcinoma or cervical carcinoma)
- Abnormal ECG
- Prolonged QT syndrome
- Current or regular use of analgesic medication for other indication(s)
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 |
|---|---|---|
| SABER-Bupivacaine Treatment 1a5.0 ml | Drug | SABER-Bupivacaine Treatment 1a |
| Placebo SABER-Bupivacaine Treatment 1bAlso: POSIMIR® bupivacaine solution5.0 ml | Drug | Placebo SABER-Bupivacaine Treatment 1b |
| Bupivacaine HCl Treatment 1c40 ml | Drug | Bupivacaine HCl Treatment 1c |
| SABER-Bupivacaine Treatment 2a7.5 ml | Drug | SABER-Bupivacaine Treatment 2a |
| Placebo SABER-Bupivacaine Treatment 2b7.5 ml | Drug | Placebo SABER-Bupivacaine Treatment 2b |
| Bupivacaine HCl Treatment 2c40 ml | Drug | Bupivacaine HCl Treatment 2c |
Primary outcome
Pain Intensity (PI)
Time frame: 1 to 72 hours post-surgery
Pain intensity (PI) on movement AUC over the period 1 to 72 hours post-surgery. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Supplemental Opioid Use
Time frame: 0-3 days after surgery
Cumulative IV morphine-equivalent dose of opioid rescue medication
2 secondary outcomes
Time to First Opioid Rescue Medication Usage
Time frame: 0-14 days after surgery
Opioid Related Side Effects
Time frame: 0-7 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- 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.
Nycomed Clinical Trial Operations study chair
Headquarters
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SABER-Bupivacaine Treatment 1a, Bupivacaine HCl Treatment 1c and SABER-Bupivacaine Treatment 2a in people with Postoperative Pain, run by Durect at 14 sites in 6 countries.
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 2 inclusion and 5 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 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Hungary, Germany, France, Latvia, Sweden and 1 more country. 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 1 Jun 2021). 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?
Pain Intensity (PI) (time frame: 1 to 72 hours post-surgery). The study lists 2 primary outcomes in all. 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 1 Jun 2021.