Major Upper or Lower Abdominal SurgeryPhase 2NCT00718081
A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery
A Phase 2 study testing Oral sufentanil in people with Major Upper or Lower Abdominal Surgery, run by Talphera, Inc at 1 site in United States.
Trial summary
The purpose of this study is to evaluate dosages of ARX-F01 (opioid pain medication) versus a placebo (or sugar pill) for the treatment of post-operative pain in subjects following abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Upper or Lower Abdominal Surgery
- What is being tested?
- Oral sufentanil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Mar 2009
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients between 18 to 80 years of age.
- Patient is scheduled to undergo an upper or lower abdominal surgery under general anesthesia.
- 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
Who cannot join
- Patient is scheduled to undergo a laparoscopically-assisted abdominal surgery.
- 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.
- Patient has any screening laboratory test value outside the laboratory normal range which is considered clinically significant by the Investigator.
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- 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 chronic abdominal pain 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 acute abdominal pain 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 drug screen test for cocaine, amphetamines, barbiturates, phencyclidine, or methadone at screening.
- Patient is receiving oxygen therapy at the time of screening.
- Patient has 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 4 hours.
- There have been any deviations from the surgical or anesthetic protocols as specified in Section 6.1.2.1.
- approved by the Institutional Review Board (IRB).
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 dosages of ARX-F01 (opioid pain medication) versus a placebo (or sugar pill) for the treatment of post-operative pain in subjects following abdominal 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
- Major Upper or Lower Abdominal Surgery
- Being tested
- Oral sufentanil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral sufentanilDrug
Oral dosage of sufentanil
PlaceboDrug
Oral dosage of placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral Sufentanil Receives: Drug: Oral sufentanil |
| 2 | Experimental | Oral sufentanil Receives: Drug: Oral sufentanil |
| 3 | Placebo comparator | Oral dosage of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID-12
The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The scores after summing could range from -122 to +122. A higher SPID-12 score is better.
Measured: 12 hours after surgery
Secondary outcomes (1)
Proportion of Patients Who Responded Very Good or Excellent in Patient Global Evaluation of Pain Relief
At the end of the 12-hour study period each patient rated their overall pain relief since starting study drug on a 5-point scale: poor, fair, good, very good or excellent.
Measured: Up to 12 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionMar 2009
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 Major Upper or Lower Abdominal SurgeryStudies 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
- 88 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
- NCT00718081
- Sponsor's protocol ID
- ARX-C-005
- Status last verified
- Dec 2014
- First submitted
- 16 Jul 2008
- Last updated
- 22 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
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 22 Jan 2015. 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 Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00718081
- Acronym / sponsor ID
- ARX-C-005
- Conditions
- Major Upper or Lower Abdominal Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Talphera, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 18 Jul 2008 (estimated)
- Results
- Posted 22 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 dosages of ARX-F01 (opioid pain medication) versus a placebo (or sugar pill) for the treatment of post-operative pain in subjects following abdominal 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
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Oral sufentanilOral Sufentanil |
| 2 | Experimental | Drug: Oral sufentanilOral sufentanil |
| 3 | Placebo comparator | Drug: PlaceboOral dosage of placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients between 18 to 80 years of age.
- Patient is scheduled to undergo an upper or lower abdominal surgery under general anesthesia.
- 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 (23 listed)
- Patient is scheduled to undergo a laparoscopically-assisted abdominal surgery.
- 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.
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 |
|---|---|---|
| Oral sufentanilOral dosage of sufentanil | Drug | 1, 2 |
| PlaceboOral dosage of placebo | Drug | 3 |
Primary outcome
SPID-12
Time frame: 12 hours after surgery
The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The scores after summing could range from -122 to +122. A higher SPID-12 score is better.
1 secondary outcome
Proportion of Patients Who Responded Very Good or Excellent in Patient Global Evaluation of Pain Relief
Time frame: Up to 12 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
- 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.
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 Oral sufentanil in people with Major Upper or Lower Abdominal Surgery, 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 23 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 22 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 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 22 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?
SPID-12 (time frame: 12 hours after surgery). 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 NCT00718081, 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 22 Jan 2015.