Post Operative PainPhase 2ARX-F01NCT00612534
A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Elective Unilateral Total Knee Replacement
A Phase 2 study testing Sufentanil NanoTab in people with Post Operative Pain, run by Talphera, Inc at 1 site in United States.
Trial summary
The purpose of this study is to evaluate three different dosage strengths of sublingual ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of post-operative pain in subjects following total knee replacement surgery. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Sufentanil NanoTab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Oct 2008
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between 45 to 80 years of age.
- Patient is scheduled for an elective, unilateral, unicondylar, bi- or tri-compartmental, cemented or uncemented knee replacement under general or spinal anesthesia that does not include use of an intrathecal opioid.
- Patient must be classified as American Society of Anesthesiologists (ASA) class I - III.
- Patient must have Body Mass Index [BMI = weight (kg)/height (m2)] between 18 and 39, inclusively.
- Female patients of childbearing potential must be using an effective method of birth control from the screening visit through the end of study. Acceptable methods of birth control include oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for ≥1 year, must be specified in the patient's case report form (CRF).
- The patient must be willing and able to understand the study procedures and the use of pain scales, and to communicate meaningfully with the study personnel.
- The patient must provide written informed consent and sign the Informed Consent approved by the Institutional Review Board (IRB).
Who cannot join
- Patient has previously undergone a knee replacement of the same knee.
- A passive range-of-motion (PRM) will be used before the 12-hour study period is complete
- Patient has previously not responded to opioid analgesics for treatment of pain.
- Patient is currently taking or has taken an opioid for more than 30 consecutive days of daily use at a daily dose equivalent to greater than 15 mg morphine within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
- Patient has an allergy or hypersensitivity to opioids.
- Patient currently has sleep apnea that has been documented by a sleep laboratory study.
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- Patient has any screening laboratory test value outside the laboratory normal range which is considered clinically significant by the Investigator.
- Patient has a contraindication to the use of general anesthesia.
- Patient is a woman who is pregnant or lactating.
- Patient has psychiatric disease or encephalopathy severe enough to prevent patient from providing reliable study documentation.
- Patient, in the Investigator's judgment, does not have adequate ability to read and understand English.
- Patient has a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including fracture or active infection.
- Patient has clinically significant renal or liver impairment which could affect metabolism or clearance of sufentanil.
- Patient has a painful physical condition other than knee arthritis that, in the opinion of the Investigator, may confound post-operative pain assessments.
- Patient has a history of drug, prescription medicine, or alcohol abuse within the past 2 years or a positive test for drugs of abuse at screening.
- Patient is receiving oxygen therapy at the time of screening.
- Patient participated in a clinical trial of an investigational drug or device within 30 days of screening visit or is scheduled to receive an investigational product other than ARX-F01 while participating in this study.
- Exclusion Criteria at Randomization (during early PACU time period):
- Patient has a respiratory rate that is less than 8 breaths per minute or greater than 24 breaths per minute,
- Patient has arterial oxygen saturation by pulse oximetry (SpO2) of less than 90% with supplemental oxygen.
- Patient is not able to answer questions and follow commands.
- Patient has vomiting that is not responsive to standard treatment.
- The surgical procedure from incision to closure was longer than 3 hours.
- There have been any deviations from the surgical or anesthetic protocols as specified in the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Trio Clinical Research
Durham, North Carolina, 27713
About this study
The purpose of this study is to evaluate three different dosage strengths of sublingual ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of post-operative pain in subjects following total knee replacement surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more often than the ARX-F01-treated subjects.
- Conditions
- Post Operative Pain
- Being tested
- Sufentanil NanoTab, Placebo NanoTab
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil NanoTabDrug
Also called ARX-F01
5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Placebo NanoTabDrug
Placebo NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Sufentanil NanoTabDrug
Also called ARX-F01
10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Sufentanil NanoTabDrug
Also called ARX-F01
15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Sufentanil NanoTab |
| 2 | Experimental | Not described Receives: Drug: Sufentanil NanoTab |
| 3 | Experimental | Not described Receives: Drug: Sufentanil NanoTab |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo NanoTab |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID-12
SPID-12 is the sum of the pain intensity difference (PID) over the 12 hour time period. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The pain score at each assessment time point is subtracted from the baseline pain score (starting point) to provide the total sum score or SPID-12. A higher SPID-12 score is better and indicates a reduction in pain intensity compared to the baseline score. Per protocol, pain scores are collected at 15 different time points. If all scores are collected, the full range of SPID-12 scores could be -150 to 150.
Measured: 12 hours after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2008
- Study completionOct 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talphera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612534
- Sponsor's protocol ID
- ARX-C-001
- Acronym
- ARX-F01
- Status last verified
- Jan 2014
- First submitted
- 28 Jan 2008
- Last updated
- 17 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Minkowitz HS, Singla NK, Evashenk MA, Hwang SS, Chiang YK, Hamel LG, Palmer PP. Pharmacokinetics of sublingual sufentanil tablets and efficacy and safety in the management of postoperative pain. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):131-9. doi: 10.1097/AAP.0b013e3182791157.
PubMed 23271030
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Elective Unilateral Total Knee Replacement
- ClinicalTrials.gov ID
- NCT00612534
- Acronym / sponsor ID
- ARX-F01 / ARX-C-001
- Conditions
- Post Operative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Talphera, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Posted 17 Feb 2014
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 three different dosage strengths of sublingual ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of post-operative pain in subjects following total knee replacement surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more often than the ARX-F01-treated subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sufentanil NanoTab |
| 2 | Experimental | Drug: Sufentanil NanoTab |
| 3 | Experimental | Drug: Sufentanil NanoTab |
| 4 | Placebo comparator | Drug: Placebo NanoTab |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients between 45 to 80 years of age.
- Patient is scheduled for an elective, unilateral, unicondylar, bi- or tri-compartmental, cemented or uncemented knee replacement under general or spinal anesthesia that does not include use of an intrathecal opioid.
- Patient must be classified as American Society of Anesthesiologists (ASA) class I - III.
- Patient must have Body Mass Index [BMI = weight (kg)/height (m2)] between 18 and 39, inclusively.
- Female patients of childbearing potential must be using an effective method of birth control from the screening visit through the end of study. Acceptable methods of birth control include oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for ≥1 year, must be specified in the patient's case report form (CRF).
Key exclusion criteria (24 listed)
- Patient has previously undergone a knee replacement of the same knee.
- A passive range-of-motion (PRM) will be used before the 12-hour study period is complete
- Patient has previously not responded to opioid analgesics for treatment of pain.
- Patient is currently taking or has taken an opioid for more than 30 consecutive days of daily use at a daily dose equivalent to greater than 15 mg morphine within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
- Patient has an allergy or hypersensitivity to opioids.
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 |
|---|---|---|
| Sufentanil NanoTabAlso: ARX-F015 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours | Drug | 1 |
| Placebo NanoTabPlacebo NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours | Drug | 4 |
| Sufentanil NanoTabAlso: ARX-F0110 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours | Drug | 2 |
| Sufentanil NanoTabAlso: ARX-F0115 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours | Drug | 3 |
Primary outcome
SPID-12
Time frame: 12 hours after first dose
SPID-12 is the sum of the pain intensity difference (PID) over the 12 hour time period. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The pain score at each assessment time point is subtracted from the baseline pain score (starting point) to provide the total sum score or SPID-12. A higher SPID-12 score is better and indicates a reduction in pain intensity compared to the baseline score. Per protocol, pain scores are collected at 15 different time points. If all scores are collected, the full range of SPID-12 scores could be -150 to 150.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23271030Minkowitz HS, Singla NK, Evashenk MA, Hwang SS, Chiang YK, Hamel LG, Palmer PP. Pharmacokinetics of sublingual sufentanil tablets and efficacy and safety in the management of postoperative pain. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):131-9. doi: 10.1097/AAP.0b013e3182791157.
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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 Sufentanil NanoTab in people with Post Operative Pain, run by Talphera, Inc 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 7 inclusion and 24 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 17 Feb 2014. 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 17 Feb 2014). 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?
SPID-12 (time frame: 12 hours after first dose). 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 NCT00612534, 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 17 Feb 2014.