BunionPhase 2NCT01435577
Intravenous Tapentadol in Post-Bunionectomy Pain
A Phase 2 study testing Tapentadol in people with Bunion and Pain, run by Grünenthal GmbH at 1 site in United States.
Trial summary
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Tapentadol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Feb 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo primary unilateral first metatarsal bunionectomy
- Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active
- Qualifying pain intensity (within a maximum of 5 hours after the last surgical stitch) and Baseline pain intensity (last pain score measured within 10 minutes before dosing) 5 on an 11-point (0 to 10) pain intensity numerical rating scale (NRS).
Who cannot join
- History of malignancy within the past 2 years
- Current or history of alcohol or drug abuse.
- Clinically relevant pulmonary, gastrointestinal, endocrine, metabolic, neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately
- History of seizure disorder, epilepsy, or any condition that would put the subject at risk of seizures
- Severely impaired renal function
- Moderately or severely impaired hepatic function
- Contraindications, or a history of allergy or hypersensitivity, to tapentadol, ibuprofen, or excipients
- Use of prohibited concomitant medication, or not allowed use of restricted concomitant medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Parallel Group, Multicenter Trial to Evaluate the Efficacy and Safety of Multiple Dose Administration of an Intravenous Formulation of Tapentadol in the Treatment of Acute Pain Following Bunionectomy.
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
- Being tested
- Tapentadol, Matching Placebo
- Keywords
- Bunionectomy, Postsurgical Pain, Acute Pain
- Medical subject headings
- Bunion, Pain, Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapentadolDrug
Also called Palexia, Nucynta
30 mg per administration, maximum 12 administrations over 48 hours
Matching PlaceboDrug
Maximum 12 administrations over 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Tapentadol intravenous | Experimental | Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone. Receives: Drug: Tapentadol |
| Matching placebo intravenous | Placebo comparator | Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain. Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Pain Intensity Differences (SPID 24)
Pain Intensity assessed at predefined time points (at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours after first drug administration) 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". Pain Intensity Differences at each predefined time point (calculated as post-baseline NRS values - baseline NRS values) were analyzed. Negative SPID24 values indicate a decrease in pain intensity and positive values indicate an increase in pain intensity since baseline.
Measured: Baseline value; up to 24 hours after first study drug administration
Secondary outcomes (23)
Mean Pain Intensity Scores at Fixed Time Points
The mean pain intensity at fixed time points in the trial for all participants is listed. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.
Measured: Baseline; up to 48 hours
Pain Intensity Differences at Fixed Time Points
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline pain intensity (prior to the first dose) and the pain intensity at the time. A negative number indicates a decrease in pain in the whole treatment group. The greater the negative pain intensity difference value the greater the pain relief in the treatment arm. A score of 0 indicates that there has been no change in pain in a treatment group. A positive value indicates an increase in pain in the treatment group.
Measured: Starting at 15 minutes and up to 48 hours after first drug administration
Patient Global Impression of Change After 12 Hours of Treatment
In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).
Measured: Baseline value to 12 hours after first study drug administration
Patients Global Impression of Change After 24 Hours of Treatment
In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).
Measured: Baseline value to 24 hours after study drug administration
Patient Global Impression of Change After 48 Hours of Treatment
In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).
Measured: Baseline value to 48 hours after first study drug administration
Sum of Pain Intensity Differences After 60 Minutes
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the value is negative then the baseline pain intensity was greater than the pain intensity measured after dosing.
Measured: Baseline value to 60 minutes after first study drug administration
Sum of Pain Intensity Differences After 4 Hours
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 4 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).
Measured: Baseline value to 4 hours after first study drug intake
Sum of Pain Intensity Differences After 8 Hours
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 8 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).
Measured: Baseline value to 8 hours after first study drug administration
Sum of Pain Intensity Differences After 12 Hours
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 12 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).
Measured: Baseline value to 12 hours after first study drug administration
Sum of Pain Intensity Differences After 48 Hours
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).
Measured: Baseline value to 48 hours after first study drug administration
Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores
Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.
Measured: Baseline value to 12 hours after first study drug administration
Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores
Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.
Measured: Baseline value to 24 hours after first study drug administration
Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores
Individual participants response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.
Measured: Baseline value to 48 hours after first study drug administration
Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores
Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.
Measured: Baseline value to 12 hours after first study drug administration
Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores
Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.
Measured: Baseline value to 24 hours after first study drug administration
Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores
Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.
Measured: Baseline value to 48 hours after first study drug administration
Time to First Rescue Medication
The median time to first rescue medication intake (600 mg ibuprofen) in hours.
Measured: up to 48 hours
Time to Perceptible Pain Relief
When the participant began to feel any pain-relieving effect after the administration of the first dose they were requested to stop the first stopwatch. The time was noted. This measured when the participant first felt any difference in the pain.
Measured: up to 48 hours
Time to Meaningful Pain Relief
The participant was instructed to stop the stopwatch when they had meaningful pain relief. That is, when the pain relief made a real difference, after the first drug administration.
Measured: up to 48 hours
Pharmacokinetic Concentrations of Tapentadol
Tapentadol concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.
Measured: 15 minutes to 20 hours after first drug administration
Pharmacokinetic Concentrations of Tapentadol-O-glucuronide
Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as "breakdown products". The body alters the administered medication to a metabolite so that can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.
Measured: 15 minutes to 20 hours after first drug administration
Mean Pain Intensity Scores at Relative Time- Tapentadol Randomized Participants
The pain intensity at the relative time points are the pain intensity before and one hour after study drug administration. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.
Measured: Baseline; for the first 6 administrations
Mean Pain Intensity Scores at Relative Time - Matching Placebo Randomized Participants
The pain intensity at the relative time points are the pain intensity before and one hour after study drug administration. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.
Measured: Baseline; for the first 6 administrations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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 BunionStudies 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
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435577
- Sponsor's protocol ID
- 295054
- Status last verified
- Oct 2019
- First submitted
- 15 Sep 2011
- Last updated
- 28 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Parallel Group, Multicenter Trial to Evaluate the Efficacy and Safety of Multiple Dose Administration of an Intravenous Formulation of Tapentadol in the Treatment of Acute Pain Following Bunionectomy.
- ClinicalTrials.gov ID
- NCT01435577
- Acronym / sponsor ID
- 295054
- Keywords
- Bunionectomy, Postsurgical Pain, Acute Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 16 Sep 2011 (estimated)
- Results
- Posted 24 Jun 2013
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 trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
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 |
|---|---|---|
| Tapentadol intravenous | Experimental | Drug: TapentadolTapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone. |
| Matching placebo intravenous | Placebo comparator | Drug: Matching PlaceboPlacebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to undergo primary unilateral first metatarsal bunionectomy
- Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active
- Qualifying pain intensity (within a maximum of 5 hours after the last surgical stitch) and Baseline pain intensity (last pain score measured within 10 minutes before dosing) 5 on an 11-point (0 to 10) pain intensity numerical rating scale (NRS).
Key exclusion criteria (8 listed)
- History of malignancy within the past 2 years
- Current or history of alcohol or drug abuse.
- Clinically relevant pulmonary, gastrointestinal, endocrine, metabolic, neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately
- History of seizure disorder, epilepsy, or any condition that would put the subject at risk of seizures
- Severely impaired renal function
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 |
|---|---|---|
| TapentadolAlso: Palexia, Nucynta30 mg per administration, maximum 12 administrations over 48 hours | Drug | Tapentadol intravenous |
| Matching PlaceboMaximum 12 administrations over 48 hours | Drug | Matching placebo intravenous |
Primary outcome
Sum of Pain Intensity Differences (SPID 24)
Time frame: Baseline value; up to 24 hours after first study drug administration
Pain Intensity assessed at predefined time points (at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours after first drug administration) 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". Pain Intensity Differences at each predefined time point (calculated as post-baseline NRS values - baseline NRS values) were analyzed. Negative SPID24 values indicate a decrease in pain intensity and positive values indicate an increase in pain intensity since baseline.
23 secondary outcomes
Mean Pain Intensity Scores at Fixed Time Points
Time frame: Baseline; up to 48 hours
Pain Intensity Differences at Fixed Time Points
Time frame: Starting at 15 minutes and up to 48 hours after first drug administration
Patient Global Impression of Change After 12 Hours of Treatment
Time frame: Baseline value to 12 hours after first study drug administration
Patients Global Impression of Change After 24 Hours of Treatment
Time frame: Baseline value to 24 hours after study drug administration
Patient Global Impression of Change After 48 Hours of Treatment
Time frame: Baseline value to 48 hours after first study drug administration
Sum of Pain Intensity Differences After 60 Minutes
Time frame: Baseline value to 60 minutes after first study drug administration
Sum of Pain Intensity Differences After 4 Hours
Time frame: Baseline value to 4 hours after first study drug intake
Sum of Pain Intensity Differences After 8 Hours
Time frame: Baseline value to 8 hours after first study drug administration
Sum of Pain Intensity Differences After 12 Hours
Time frame: Baseline value to 12 hours after first study drug administration
Sum of Pain Intensity Differences After 48 Hours
Time frame: Baseline value to 48 hours after first study drug administration
Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores
Time frame: Baseline value to 12 hours after first study drug administration
Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores
Time frame: Baseline value to 24 hours after first study drug administration
Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores
Time frame: Baseline value to 48 hours after first study drug administration
Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores
Time frame: Baseline value to 12 hours after first study drug administration
Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores
Time frame: Baseline value to 24 hours after first study drug administration
Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores
Time frame: Baseline value to 48 hours after first study drug administration
Time to First Rescue Medication
Time frame: up to 48 hours
Time to Perceptible Pain Relief
Time frame: up to 48 hours
Time to Meaningful Pain Relief
Time frame: up to 48 hours
Pharmacokinetic Concentrations of Tapentadol
Time frame: 15 minutes to 20 hours after first drug administration
Pharmacokinetic Concentrations of Tapentadol-O-glucuronide
Time frame: 15 minutes to 20 hours after first drug administration
Mean Pain Intensity Scores at Relative Time- Tapentadol Randomized Participants
Time frame: Baseline; for the first 6 administrations
Mean Pain Intensity Scores at Relative Time - Matching Placebo Randomized Participants
Time frame: Baseline; for the first 6 administrations
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tapentadol in people with Bunion and Pain, run by Grünenthal GmbH 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 3 inclusion and 8 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 28 Oct 2019. 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 24 Jun 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?
Sum of Pain Intensity Differences (SPID 24) (time frame: Baseline value; up to 24 hours after first study drug administration). 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 28 Oct 2019.