BunionectomyPhase 3NCT00609466
A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
A Phase 3 study testing CG5503 IR and Morphine in people with Bunionectomy and Pain, run by Grünenthal GmbH at 6 sites in United States.
Trial summary
The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects following bunionectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bunionectomy, Pain, Postoperative Pain
- What is being tested?
- CG5503 IR and Morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 291 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2007to Feb 2008
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects between 18 and 80 years of age;
- Scheduled to undergo primary unilateral first metatarsal bunionectomy;
- Anesthesiological and surgical procedures performed according to protocol;
- Moderate or severe baseline pain following bunionectomy on a VRS within 9 hours of termination of the continuous popliteal sciatic block or systemic analgesia;
- Pain following bunionectomy of at least 4 on an 11-point NRS within 9 hours of termination of the continuous popliteal sciatic block or systemic analgesia; American Society of Anesthesiologists (ASA) classification I-III.
Who cannot join
- History of seizure disorder;
- History of alcohol, medication or drug dependency, unstable psychological personality requiring intermittent or permanent treatment; severely impaired renal function, moderately or severely impaired hepatic function;
- Contraindications to, or history of allergy or hypersensitivity to CG5503, oxycodone, morphine, fentanyl hydrocodone, acetaminophen, heparin, or any compound planned to be used during the anesthesia, or their excipients;
- Pre-operative use within 12h prior to surgery or peri-operative use of non- steroidal anti-inflammatory drugs (NSAIDs);
- Treated regularly with opioid analgesic or NSAIDs within 30 days prior to screening;
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Site 101
Austin, Texas, 78705
Site 102
Houston, Texas, 77081
Site 104
Pasadena, Maryland, 21122
Site 106
Salt Lake City, Utah, 84117
Site 105
San Antonio, Texas, 78229
Site 103
San Marcos, Texas, 78666
About this study
Official title: A Randomized, Double-blind, Parallel-group, Multi-center, Active- and Placebo-controlled Trial to Evaluate the Analgesic Efficacy and Safety of Multiple Doses of CG5503 IR for Postoperative Pain Following Bunionectomy
The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects following bunionectomy.
This trial was performed based on a previously performed double-blind, placebo-controlled, multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75 and 100 mg) published under PMID: 18851776.
Read the detailed description
Subjects undergoing bunionectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. CG5503, a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this trial is to investigate the effectiveness (level of pain control) and safety (side effects) of CG5503 IR 75mg compared with no drug (placebo) or one dose of morphine (an opioid commonly used to treat post-surgical pain). This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter trial to evaluate the treatment of acute pain after bunionectomy. The trial will include a blinded 72 hour inpatient phase immediately following bunionectomy, during which subjects will be treated with either 75-mg CG5503 IR, a placebo, or 30-mg morphine, and pain relief will be periodically assessed. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR), and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and morphine. The alternative trial hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 48 hours.
- Conditions
- Bunionectomy, Pain, Postoperative Pain, Acute Pain
- Being tested
- CG5503 IR, Morphine, Placebo
- Keywords
- Opioid, Central acting analgesic, CG5503 IR, Postoperative pain, Bunionectomy, Morphine, Placebo
- Medical subject headings
- Pain, Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG5503 IRDrug
75mg IR 4 - 6 hourly Total: 72 hours
MorphineDrug
Morphine 30 mg IR 4 - 6 hourly Total: 72 hours
PlaceboDrug
Placebo; 4 - 6 hourly; Total: 72 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CG5503 IR 75mg 4 to 6 hourly for 72 hours Receives: Drug: CG5503 IR |
| 2 | Active comparator | Morphine IR 30 mg 4 to 6 hourly for 72 hours Receives: Drug: Morphine |
| 3 | Placebo comparator | Matching placebo 4 to 6 hourly for 72 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.
Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain).
Measured: Baseline value to 48 hours after first study drug intake.
Secondary outcomes (6)
Number of Participants Using Rescue Medication
Number of participants who used at least one dose of rescue medication during the 72 hour double blind period.
Measured: Baseline up to 72 hours after first study drug intake
Total Pain Relief (TOTPAR)
Total pain relief (TOTPAR) in the 48 hour period from the first dose of study drug. The subject was to indicate pain relief at rest in response to the following question: How much relief have you had from your starting pain? None = 0, A little = 1, Some = 2, A lot = 3 and Complete = 4. The theoretical maximum range of Total pain relief (TOTPAR)48 is from 0 (indicative of no pain relief) to 192. The higher the value the better the pain relief.
Measured: Baseline to 48 hours after first study drug intake
Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity
Pain Intensity assessed at predefined time points over a 6 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID6) is from -60 (indicative of an increase in pain) to 60 (indicative of a decrease in pain).
Measured: Baseline to 6 hours after intake of first study drug
Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity
Pain Intensity assessed at predefined time points over a 12 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID12) is from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain).
Measured: Baseline to 12 hours after first study drug intake
Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity
Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain).
Measured: Baseline to 24 hours after first study drug intake
Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity
Pain Intensity assessed at predefined time points over a 72 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID72) is from -720 (indicative of an increase in pain) to 720 (indicative of a decrease in pain).
Measured: Baseline to 72 hours after first intake of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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 BunionectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Stephen E Daniels, DO, Principal investigator, Premier Research Group (formerly SCIREX Corporation)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609466
- Sponsor's protocol ID
- 574139
- Status last verified
- Nov 2011
- First submitted
- 24 Jan 2008
- Last updated
- 16 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Multi-center, Active- and Placebo-controlled Trial to Evaluate the Analgesic Efficacy and Safety of Multiple Doses of CG5503 IR for Postoperative Pain Following Bunionectomy
- ClinicalTrials.gov ID
- NCT00609466
- Acronym / sponsor ID
- 574139
- Conditions
- Bunionectomy, Pain, Postoperative Pain, Acute Pain
- Keywords
- Opioid, Central acting analgesic, CG5503 IR, Postoperative pain, Bunionectomy, Morphine, Placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Posted 25 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects following bunionectomy.
This trial was performed based on a previously performed double-blind, placebo-controlled, multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75 and 100 mg) published under PMID: 18851776.
Detailed description
Subjects undergoing bunionectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. CG5503, a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this trial is to investigate the effectiveness (level of pain control) and safety (side effects) of CG5503 IR 75mg compared with no drug (placebo) or one dose of morphine (an opioid commonly used to treat post-surgical pain). This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter trial to evaluate the treatment of acute pain after bunionectomy. The trial will include a blinded 72 hour inpatient phase immediately following bunionectomy, during which subjects will be treated with either 75-mg CG5503 IR, a placebo, or 30-mg morphine, and pain relief will be periodically assessed. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR), and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and morphine. The alternative trial hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CG5503 IRCG5503 IR 75mg 4 to 6 hourly for 72 hours |
| 2 | Active comparator | Drug: MorphineMorphine IR 30 mg 4 to 6 hourly for 72 hours |
| 3 | Placebo comparator | Drug: PlaceboMatching placebo 4 to 6 hourly for 72 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects between 18 and 80 years of age;
- Scheduled to undergo primary unilateral first metatarsal bunionectomy;
- Anesthesiological and surgical procedures performed according to protocol;
- Moderate or severe baseline pain following bunionectomy on a VRS within 9 hours of termination of the continuous popliteal sciatic block or systemic analgesia;
- Pain following bunionectomy of at least 4 on an 11-point NRS within 9 hours of termination of the continuous popliteal sciatic block or systemic analgesia; American Society of Anesthesiologists (ASA) classification I-III.
Key exclusion criteria (5 listed)
- History of seizure disorder;
- History of alcohol, medication or drug dependency, unstable psychological personality requiring intermittent or permanent treatment; severely impaired renal function, moderately or severely impaired hepatic function;
- Contraindications to, or history of allergy or hypersensitivity to CG5503, oxycodone, morphine, fentanyl hydrocodone, acetaminophen, heparin, or any compound planned to be used during the anesthesia, or their excipients;
- Pre-operative use within 12h prior to surgery or peri-operative use of non- steroidal anti-inflammatory drugs (NSAIDs);
- Treated regularly with opioid analgesic or NSAIDs within 30 days prior to screening;
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 |
|---|---|---|
| CG5503 IR75mg IR 4 - 6 hourly Total: 72 hours | Drug | 1 |
| MorphineMorphine 30 mg IR 4 - 6 hourly Total: 72 hours | Drug | 2 |
| PlaceboPlacebo; 4 - 6 hourly; Total: 72 hours | Drug | 3 |
Primary outcome
Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.
Time frame: Baseline value to 48 hours after first study drug intake.
Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain).
6 secondary outcomes
Number of Participants Using Rescue Medication
Time frame: Baseline up to 72 hours after first study drug intake
Total Pain Relief (TOTPAR)
Time frame: Baseline to 48 hours after first study drug intake
Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity
Time frame: Baseline to 6 hours after intake of first study drug
Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity
Time frame: Baseline to 12 hours after first study drug intake
Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity
Time frame: Baseline to 24 hours after first study drug intake
Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity
Time frame: Baseline to 72 hours after first intake of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bunionectomy
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Postsurgical Analgesia After Unilateral Bunionectomy
Bunionectomy, Bunion
Not yet recruitingPhase 3
Phase 3 Bunionectomy Study
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Not yet recruitingPhase 2
A Clinical Trial of GRT7040 in Adults With Acute Pain Following Bunionectomy
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Active, not recruitingPhase 3
A Study of TLC590 for Postsurgical Pain Following Bunionectomy
Postoperative Pain
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.
Stephen E Daniels, DO principal investigator
Premier Research Group (formerly SCIREX Corporation)
6 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 CG5503 IR and Morphine in people with Bunionectomy and Pain, run by Grünenthal GmbH at 6 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 5 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 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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 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 25 Nov 2009). 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?
Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. (time frame: Baseline value to 48 hours after first study drug intake.). 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 16 Nov 2011.