Postoperative PainPhase 2NCT02197156
A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery
A Phase 2 study testing 10 mg HC-ER, 20 mg HC-ER and 30 mg HC-ER in people with Postoperative Pain, run by Zogenix, Inc..
Trial summary
The purpose of the study is to establish a dose-response relationship among several capsule strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to placebo following bunionectomy surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- 10 mg HC-ER, 20 mg HC-ER and 30 mg HC-ER
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 241 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Feb 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Subject was able to read and voluntarily sign the Institutional Review Board (IRB) approved, written informed consent document and given the opportunity to ask questions regarding the study prior to the performance of any study- specific procedures.
- Subject required primary unilateral first metatarsal bunionectomy surgery with or without hammertoe repair with no other collateral procedures allowed
- Subject was male or female at least 18 years of age.
- Subject weighed > or = 100 lbs (pounds).
- Subject was willing and able to comply with the protocol and able to score their pain intensity.
- Subject was in good health as determined by the investigator on the basis of medical history, physical examination, Electrocardiogram (ECG) and screening laboratory results.
- Subject had not developed a condition or complications as result of the bunionectomy procedure that would preclude their participation in the study.
- Subject was willing and able to remain at the recovery day care center for the entire 24-hour Treatment period.
Who cannot join
- Subject was pregnant or lactating.
- Subject had been on an investigational drug within 30 days prior to the initiation of study drug.
- Subject had donated blood or blood components within one month prior to study (Check-in).
- Subject had a know allergy or hypersensitivity to opioids, acetaminophen, and/or ketorolac.
- Subject had a known history of substance or alcohol abuse within 2 years prior to Screening.
- Subject tested positive to drug screens (cocaine, marijuana, opioids, benzodiazepines, and barbiturates) that could not be justified by prescription use.
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- Subject had a condition that would contraindicate the use of opioid analgesia (e.g., pulmonary disease or paralytic ileus).
- Subject had received a selective serotonin reuptake inhibitor (SSRI), monoamine oxidase inhibitor (MAOI) carbamazepine, quinidine, and/or tricyclic antidepressants (TCA) compounds within 1-month prior to Check-in.
- Subject had received opioids, tranquilizers, sedatives, or hypnotics within 48 hours prior to Check-in.
- Subject had received corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other analgesics within 24 hours prior to Check-in.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Active Comparator Study of Hydrocodone Bitartrate Extended Release (HC-ER) in Adults Following Bunionectomy Surgery
The purpose of the study is to establish a dose-response relationship among several capsule strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to placebo following bunionectomy surgery
Read the detailed description
Sum of Pain Intensity Differences (SPID) for the Primary pain measurement: VASPI (Visual Analog Scale of Pain Intensity) from time 0 to 12 hrs; Safety evaluations assessed: laboratory evaluations, physical examinations, vital signs/pulse oximetry and electrocardiography
- Conditions
- Postoperative Pain
- Being tested
- 10 mg HC-ER, 20 mg HC-ER, 30 mg HC-ER, 40 mg HC-ER, 10 mg HC / 325 mg APAP
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg HC-ERDrug
Also called ELN154088, Hydrocodone bitartrate extended release (HC-ER), Zohydro Extended Release (ER)
Single dose
20 mg HC-ERDrug
Also called ELN154088, Hydrocodone bitartrate extended release (HC-ER) 10 mg, Zohydro Extended Release (ER)
Single dose
30 mg HC-ERDrug
Also called ELN154088, Hydrocodone bitartrate extended release (HC-ER) 30 mg, Zohydro Extended Release (ER)
Single dose
40 mg HC-ERDrug
Also called ELN154088, Hydrocodone bitartrate extended release (HC-ER) 40 mg, Zohydro Extended Release (ER)
Single dose
10 mg HC / 325 mg APAPDrug
Also called 10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)
Single dose
Matching PlaceboDrug
Also called Placebo
Single dose
| Study group | Role | What they receive |
|---|---|---|
| 10 mg HC-ER | Experimental | Hydrocodone bitartrate extended release (HC-ER) 10 mg Receives: Drug: 10 mg HC-ER |
| 20 mg HC-ER | Experimental | Hydrocodone bitartrate extended release (HC-ER) 20 mg Receives: Drug: 20 mg HC-ER |
| 30 mg HC-ER | Experimental | Hydrocodone bitartrate extended release (HC-ER) 30 mg Receives: Drug: 30 mg HC-ER |
| 40 mg HC-ER | Experimental | Hydrocodone bitartrate extended release (HC-ER) 40 mg Receives: Drug: 40 mg HC-ER |
| 10 mg HC / 325 mg APAP | Active comparator | 10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP) Receives: Drug: 10 mg HC / 325 mg APAP |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Sum of Pain Intensity Differences (SPID) for the Visual Analog Scale Pain Intensity (VASPI)
Measured: 0-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startAug 2002
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zogenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197156
- Sponsor's protocol ID
- ELN154088-201
- Status last verified
- Jul 2014
- First submitted
- 21 Jul 2014
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Active Comparator Study of Hydrocodone Bitartrate Extended Release (HC-ER) in Adults Following Bunionectomy Surgery
- ClinicalTrials.gov ID
- NCT02197156
- Acronym / sponsor ID
- ELN154088-201
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Zogenix, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
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 the study is to establish a dose-response relationship among several capsule strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to placebo following bunionectomy surgery
Detailed description
Sum of Pain Intensity Differences (SPID) for the Primary pain measurement: VASPI (Visual Analog Scale of Pain Intensity) from time 0 to 12 hrs; Safety evaluations assessed: laboratory evaluations, physical examinations, vital signs/pulse oximetry and electrocardiography
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 10 mg HC-ER | Experimental | Drug: 10 mg HC-ERHydrocodone bitartrate extended release (HC-ER) 10 mg |
| 20 mg HC-ER | Experimental | Drug: 20 mg HC-ERHydrocodone bitartrate extended release (HC-ER) 20 mg |
| 30 mg HC-ER | Experimental | Drug: 30 mg HC-ERHydrocodone bitartrate extended release (HC-ER) 30 mg |
| 40 mg HC-ER | Experimental | Drug: 40 mg HC-ERHydrocodone bitartrate extended release (HC-ER) 40 mg |
| 10 mg HC / 325 mg APAP | Active comparator | Drug: 10 mg HC / 325 mg APAP10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP) |
| Placebo | Placebo comparator | Drug: Matching PlaceboMatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject was able to read and voluntarily sign the Institutional Review Board (IRB) approved, written informed consent document and given the opportunity to ask questions regarding the study prior to the performance of any study- specific procedures.
- Subject required primary unilateral first metatarsal bunionectomy surgery with or without hammertoe repair with no other collateral procedures allowed
- Subject was male or female at least 18 years of age.
- Subject weighed > or = 100 lbs (pounds).
- Subject was willing and able to comply with the protocol and able to score their pain intensity.
Key exclusion criteria (10 listed)
- Subject was pregnant or lactating.
- Subject had been on an investigational drug within 30 days prior to the initiation of study drug.
- Subject had donated blood or blood components within one month prior to study (Check-in).
- Subject had a know allergy or hypersensitivity to opioids, acetaminophen, and/or ketorolac.
- Subject had a known history of substance or alcohol abuse within 2 years 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 |
|---|---|---|
| 10 mg HC-ERAlso: ELN154088, Hydrocodone bitartrate extended release (HC-ER), Zohydro Extended Release (ER)Single dose | Drug | 10 mg HC-ER |
| 20 mg HC-ERAlso: ELN154088, Hydrocodone bitartrate extended release (HC-ER) 10 mg, Zohydro Extended Release (ER)Single dose | Drug | 20 mg HC-ER |
| 30 mg HC-ERAlso: ELN154088, Hydrocodone bitartrate extended release (HC-ER) 30 mg, Zohydro Extended Release (ER)Single dose | Drug | 30 mg HC-ER |
| 40 mg HC-ERAlso: ELN154088, Hydrocodone bitartrate extended release (HC-ER) 40 mg, Zohydro Extended Release (ER)Single dose | Drug | 40 mg HC-ER |
| 10 mg HC / 325 mg APAPAlso: 10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)Single dose | Drug | 10 mg HC / 325 mg APAP |
| Matching PlaceboAlso: PlaceboSingle dose | Drug | Placebo |
Primary outcome
The Sum of Pain Intensity Differences (SPID) for the Visual Analog Scale Pain Intensity (VASPI)
Time frame: 0-12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10 mg HC-ER, 20 mg HC-ER and 30 mg HC-ER in people with Postoperative Pain, run by Zogenix, Inc..
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 10 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 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Sum of Pain Intensity Differences (SPID) for the Visual Analog Scale Pain Intensity (VASPI) (time frame: 0-12 hours). 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 10 Nov 2022.