Hallux ValgusPhase 3NCT01813890
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo
A Phase 3 study testing Tapentadol IR 50 mg and Tapentadol IR 75 mg in people with Hallux Valgus, run by Janssen-Cilag International NV at 3 sites in Taiwan.
Trial summary
The purpose of this study is to evaluate the analgesic efficacy and safety of tapentadol immediate-release (IR [CG5503]) for use in the relief of moderate to severe acute pain, compared with placebo, in adult Taiwanese patients with acute pain following bunionectomy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Tapentadol IR 50 mg and Tapentadol IR 75 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesTaiwan
- Study dates
- Jan 2013to Jan 2014
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be undergoing primary unilateral first metatarsal bunionectomy that includes a distal Chevron osteotomy only, with or without the Akin procedure
- Patients must be healthy or medically stable on the basis of clinical laboratory tests performed at screening
- Women must be postmenopausal, surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control and have a negative serum pregnancy test at screening and a negative urine pregnancy test before surgery
- If a male, must use an approved method of birth control and does not donate sperm from the day of study drug administration until 3 months afterwards
- Qualifying baseline Pain Intensity must be rated as greater than or equal to 4 on an 11-point (0 to 10) PI NRS, recorded within 30 minutes before randomization, no earlier than 10 hours after the first surgical incision and within 9 hours after termination of the continuous Popliteal Sciatic Block (PSB) infusion Exclusion Criteria: - History of seizure disorder or epilepsy, severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours duration, malignancy in the past 2 years with the exception of successfully treated basal cell carcinoma
- Mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening
- Renal insufficiency, impaired hepatic function
- Use of anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, serotonin norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs) or triptans
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Tapentadol Immediate-Release Formulation in the Treatment of Acute Pain From Bunionectomy
The purpose of this study is to evaluate the analgesic efficacy and safety of tapentadol immediate-release (IR [CG5503]) for use in the relief of moderate to severe acute pain, compared with placebo, in adult Taiwanese patients with acute pain following bunionectomy.
Read the detailed description
Patients undergoing bunionectomy (a surgical procedure to remove a bunion, an enlargement of the joint at the base of the big toe comprised of bone and soft tissue) often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when patients receive repeated doses of opioid analgesics. Tapentadol (CG5503) is a newly synthesized opioid drug acting as a centrally acting analgesic like opioid analgesics but has a different mode of action. This study, a randomized (patients are assigned different treatments based on chance), double-blind (neither investigator nor patient knows which treatment the patient receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each group of patients will be treated at the same time), multicenter study (the study is performed at more than one clinic) is designed to evaluate the effectiveness (level of pain control) and safety (side effects) of tapentadol immediate-release (IR) 50 mg or 75 mg versus placebo. The study will consist of a screening phase, during which the patients will be evaluated for study entry (Days -28 to -2) followed by the surgical period (Day -1) during which the bunionectomy will be performed and which will start with the first surgical incision and continues until termination of the popliteal sciatic block (PSB) infusion. During the qualification period (Day 1) which starts after termination of the post-operative continuous PSB infusion, patients will be evaluated for entry in the double blind treatment phase. Patients will be randomly assigned to one of three treatment groups to receive either 50 mg tapentadol IR, 75 mg tapentadol IR or a placebo if their PI is equal to or greater than 4 on a 0-10 numerical rating scale. The inpatient double-blind treatment period will be 72 hours in duration and will include a final end-of-double-blind evaluation (on Day 4, i.e., 72 hours after the administration of the first dose) for all patients. Any patient requiring analgesia for pain relief in addition to study drug during the double-blind treatment period will be discontinued from the study due to lack of efficacy. All patients who discontinue for lack of efficacy will complete pain assessments and the Patient Global Impression of Change (PGIC) before receiving rescue medication. Pain intensity and pain relief will be periodically assessed during the treatment period using rating scales. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. The study length, including the screening period, will be up to a maximum duration of 32 days.
- Conditions
- Hallux Valgus
- Being tested
- Tapentadol IR 50 mg, Tapentadol IR 75 mg, Placebo
- Keywords
- Bunionectomy, Acute pain, Post-operative pain, Tapentadol IR, Analgesia, Hallux valgus
- Medical subject headings
- Hallux Valgus, Acute Pain, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol IR 50 mgDrug
Tapentadol IR 50 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
Tapentadol IR 75 mgDrug
Tapentadol IR 75 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
PlaceboDrug
Placebo will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Tapentadol IR 50 mg | Experimental | Not described Receives: Drug: Tapentadol IR 50 mg |
| Tapentadol IR 75 mg | Experimental | Not described Receives: Drug: Tapentadol IR 75 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Pain Intensity Difference (SPID) Over 48 Hours
Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.
Measured: 48 hours
Secondary outcomes (7)
Time to First Rescue Medication Use
Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.
Measured: up to 48 hours
Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours
Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.
Measured: 12, 24, 48 and 72 hours
Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours
Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.
Measured: 12, 24, 48 and 72 hours
Sum of Pain Intensity Differences (SPID) Over 12, 24 and 72 Hours
Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.
Measured: 12, 24 and 72 hours
Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours
Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.
Measured: 12, 24, 48, and 72 hours
Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours
Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.
Measured: 12, 24, 48 and 72 hours
Patient Global Impression of Change (PGI-C) Score at 72 Hours
The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.
Measured: Baseline (Day 1) and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
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 Hallux ValgusStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813890
- Sponsor's protocol ID
- CR101093
- Other IDs
- R331333PAI3035
- Status last verified
- Dec 2014
- First submitted
- 15 Mar 2013
- Last updated
- 9 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chen YJ, Chiang CC, Huang PJ, Huang J, Karcher K, Li H. Tapentadol immediate-release for acute postbunionectomy pain: a phase 3, randomized, double-blind, placebo-controlled, parallel-group study in Taiwan. Curr Med Res Opin. 2015 Nov;31(11):2001-9. doi: 10.1185/03007995.2015.1082992. Epub 2015 Sep 21.
PubMed 26293513
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Tapentadol Immediate-Release Formulation in the Treatment of Acute Pain From Bunionectomy
- ClinicalTrials.gov ID
- NCT01813890
- Acronym / sponsor ID
- CR101093
- Conditions
- Hallux Valgus
- Keywords
- Bunionectomy, Acute pain, Post-operative pain, Tapentadol IR, Analgesia, Hallux valgus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Posted 9 Jan 2015
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 evaluate the analgesic efficacy and safety of tapentadol immediate-release (IR [CG5503]) for use in the relief of moderate to severe acute pain, compared with placebo, in adult Taiwanese patients with acute pain following bunionectomy.
Detailed description
Patients undergoing bunionectomy (a surgical procedure to remove a bunion, an enlargement of the joint at the base of the big toe comprised of bone and soft tissue) often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when patients receive repeated doses of opioid analgesics. Tapentadol (CG5503) is a newly synthesized opioid drug acting as a centrally acting analgesic like opioid analgesics but has a different mode of action. This study, a randomized (patients are assigned different treatments based on chance), double-blind (neither investigator nor patient knows which treatment the patient receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each group of patients will be treated at the same time), multicenter study (the study is performed at more than one clinic) is designed to evaluate the effectiveness (level of pain control) and safety (side effects) of tapentadol immediate-release (IR) 50 mg or 75 mg versus placebo. The study will consist of a screening phase, during which the patients will be evaluated for study entry (Days -28 to -2) followed by the surgical period (Day -1) during which the bunionectomy will be performed and which will start with the first surgical incision and continues until termination of the popliteal sciatic block (PSB) infusion. During the qualification period (Day 1) which starts after termination of the post-operative continuous PSB infusion, patients will be evaluated for entry in the double blind treatment phase. Patients will be randomly assigned to one of three treatment groups to receive either 50 mg tapentadol IR, 75 mg tapentadol IR or a placebo if their PI is equal to or greater than 4 on a 0-10 numerical rating scale. The inpatient double-blind treatment period will be 72 hours in duration and will include a final end-of-double-blind evaluation (on Day 4, i.e., 72 hours after the administration of the first dose) for all patients. Any patient requiring analgesia for pain relief in addition to study drug during the double-blind treatment period will be discontinued from the study due to lack of efficacy. All patients who discontinue for lack of efficacy will complete pain assessments and the Patient Global Impression of Change (PGIC) before receiving rescue medication. Pain intensity and pain relief will be periodically assessed during the treatment period using rating scales. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. The study length, including the screening period, will be up to a maximum duration of 32 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tapentadol IR 50 mg | Experimental | Drug: Tapentadol IR 50 mg |
| Tapentadol IR 75 mg | Experimental | Drug: Tapentadol IR 75 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must be undergoing primary unilateral first metatarsal bunionectomy that includes a distal Chevron osteotomy only, with or without the Akin procedure
- Patients must be healthy or medically stable on the basis of clinical laboratory tests performed at screening
- Women must be postmenopausal, surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control and have a negative serum pregnancy test at screening and a negative urine pregnancy test before surgery
- If a male, must use an approved method of birth control and does not donate sperm from the day of study drug administration until 3 months afterwards
- Qualifying baseline Pain Intensity must be rated as greater than or equal to 4 on an 11-point (0 to 10) PI NRS, recorded within 30 minutes before randomization, no earlier than 10 hours after the first surgical incision and within 9 hours after termination of the continuous Popliteal Sciatic Block (PSB) infusion Exclusion Criteria: - History of seizure disorder or epilepsy, severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours duration, malignancy in the past 2 years with the exception of successfully treated basal cell carcinoma
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Tapentadol IR 50 mgTapentadol IR 50 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period. | Drug | Tapentadol IR 50 mg |
| Tapentadol IR 75 mgTapentadol IR 75 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period. | Drug | Tapentadol IR 75 mg |
| PlaceboPlacebo will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period. | Drug | Placebo |
Primary outcome
Sum of Pain Intensity Difference (SPID) Over 48 Hours
Time frame: 48 hours
Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.
7 secondary outcomes
Time to First Rescue Medication Use
Time frame: up to 48 hours
Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours
Time frame: 12, 24, 48 and 72 hours
Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours
Time frame: 12, 24, 48 and 72 hours
Sum of Pain Intensity Differences (SPID) Over 12, 24 and 72 Hours
Time frame: 12, 24 and 72 hours
Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours
Time frame: 12, 24, 48, and 72 hours
Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours
Time frame: 12, 24, 48 and 72 hours
Patient Global Impression of Change (PGI-C) Score at 72 Hours
Time frame: Baseline (Day 1) and 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26293513Chen YJ, Chiang CC, Huang PJ, Huang J, Karcher K, Li H. Tapentadol immediate-release for acute postbunionectomy pain: a phase 3, randomized, double-blind, placebo-controlled, parallel-group study in Taiwan. Curr Med Res Opin. 2015 Nov;31(11):2001-9. doi: 10.1185/03007995.2015.1082992. Epub 2015 Sep 21.
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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.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
3 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 Tapentadol IR 50 mg and Tapentadol IR 75 mg in people with Hallux Valgus, run by Janssen-Cilag International NV at 3 sites in Taiwan.
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 8 inclusion and 0 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 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. 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 9 Jan 2015). 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 Difference (SPID) Over 48 Hours (time frame: 48 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 NCT01813890, 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 9 Jan 2015.