CancerPhase 2NCT00833040
A Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 (Sufentanil NanoTab) Compared to Placebo in the Treatment of Cancer Breakthrough Pain
A Phase 2 study of Cancer and Pain, run by Talphera, Inc at 13 sites in United States.
Trial summary
The purpose of this research study was to evaluate ARX-F02 (Sufentanil NanoTab) versus placebo ("sugar" pill or inactive substance) in the management of breakthrough pain in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2009to Mar 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older with documented clinical history or evidence of a malignancy.
- Patients must have sufficient pain to require at least the equivalent of 60 mg/day oral morphine, at least 25 mcg/hr transdermal fentanyl, at least 30 mg/day oxycodone, at least 8 mg/day oral hydromorphone for a week or longer.
- Patient is experiencing 1 - 4 episodes of cancer breakthrough pain per day, on average but not necessarily every day, requiring use of an additional opioid analgesic.
- Patient has a life expectancy of at least 3 months.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status rating < 2.
- Patient must be able to provide reliable documentation of pain intensity, pain relief, use of rescue medication, and global evaluation of treatment personally or with the help of a caregiver.
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- Patient must be able to enter simple commands on a Palm Pilot device, personally or with the help of a caregiver.
- If patient is female and of childbearing potential she must have a negative urine pregnancy test at screening, and must use medically acceptable methods of birth control. Acceptable methods of birth control include oral or transdermal contraceptives, condom, spermicidal foam, 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 1 year or more postmenopausal must be specified in the patient's CRF.
- Patient must demonstrate the dexterity to handle the single-dose applicator that will be used for placing the NanoTab™ under the tongue.
- Patient and/or caregiver must demonstrate ability to use the NanoTab™ retrieval tool.
- There must be a caregiver in the home (or hospice) who will be present for at least 1 hour following each dose during titration.
- Patient must provide written informed consent.
Who cannot join
- Patients with uncontrollable or rapidly escalating pain.
- Patients with a history of psychiatric disease or loss of cognitive function that would prevent patient from providing reliable study documentation.
- Patients with oral mucositis or stomatitis.
- Patients with a history of substance abuse within the past year.
- Patients who are using intrathecal opioids.
- Patients with underlying pulmonary disease such as sleep apnea or chronic obstructive pulmonary disease characterized by CO2 retention that is deemed clinically significant by the investigator.
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- Patients at risk of significant bradyarrhythmia, in the opinion of the Investigator, due to underlying heart disease.
- Patients with abnormal chemistry or hematology that are deemed by the investigator to be clinically significant. Abnormalities that are cancer related should be documented.
- Patients with clinically significant abnormality on the Screening ECG who, in the Investigator's opinion, should not participate in the study.
- Patients who will be receiving chemotherapy or radiation treatment during the 3-week titration phase or 3-week double-blind phase that, in the Investigator's opinion, may dramatically alter the patient's pain level or response to pain medications.
- Patients who are taking monoamine oxidase inhibitors (MAOIs), or have taken MAOIs within 14 days prior to enrolling in the study.
- Patients who have participated in a clinical trial of an investigational drug or device within 30 days of screening visit.
- Patients who, in the Investigator's opinion, should not participate in the study or may not be capable of following the study schedule or procedures for any reason.
- Patients who are employees or family members of the Investigator, study center or AcelRx.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Gabrail Cancer Center
Canton, Ohio, 44718
Four Seasons Hospice & Palliative Care
Flat Rock, North Carolina, 28731
Research Concepts Ltd
Houston, Texas, 77024
Florida Institute of Medical Research
Jacksonville, Florida, 32257
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Drug Studies America, Inc.
Marietta, Georgia, 30060
Clinical Trials and Research Associates
Montebello, California, 90640
Better Health Clinical Research, Inc.
Newnan, Georgia, 30265
International Clinical Research Institute
Overland Park, Kansas, 66211
Sarasota Pain Medicine Research
Sarasota, Florida, 34238
Willis-Knighton Pain Management Center
Shreveport, Louisiana, 71103
Lovelace Scientific Resources
Venice, Florida, 34292
Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multicenter, Randomized, Placebo-Controlled, Crossover Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 Compared to Placebo in the Treatment of Cancer Breakthrough Pain
The purpose of this research study was to evaluate ARX-F02 (Sufentanil NanoTab) versus placebo ("sugar" pill or inactive substance) in the management of breakthrough pain in cancer patients.
- Being tested
- Sublingual sufentanil NanoTabs™ and placebo NanoTabs™
- Keywords
- Cancer breakthrough pain
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual sufentanil NanoTabs™ and placebo NanoTabs™Drug
Also called (ARX-F02)
During the Titration Phase, patients titrated to the dose of sufentanil that provided adequate pain relief without intolerable side effects. Dosages were 20, 30, 40, 60 and 80 mcg. During the Double Blind Phase, patients were randomized to one of six sequences and took 7 doses of sufentanil (dosage determined in the titration phase, and 3 doses of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Titration of sufentanil, the DBL sufentanil & PBO | Experimental | During the Titration Phase, patients titrated to the effective dosage of sublingual sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sublingual sufentanil NanoTab™ was taken as needed for breakthrough pain.
During the Double-Blind Phase, patients were then randomized to one of six treatment sequences, each of which included seven active doses of sublingual sufentanil (dosage determined in Titration Phase) and three placebo doses taken in random order. One NanoTab™ was taken as needed for breakthrough pain. Receives: Drug: Sublingual sufentanil NanoTabs™ and placebo NanoTabs™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted SPID30
time-weighted SPID30 is the sum of the pain intensity difference (PID) over the 30 minute time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is recorded at pre-dose, 10, 15, 30, 45, and 60 minutes post-dose. The pain score at each assessment time through 30 minutes is subtracted from the baseline pain score to provide the total sum score or SPID30. A higher SPID30 is better and indicates a reduction in pain intensity compared to the baseline score.
Measured: 30 minutes after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2010
- Study completionMar 2010
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 CancerStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 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
- NCT00833040
- Sponsor's protocol ID
- ARX-C-003
- Status last verified
- Dec 2014
- First submitted
- 28 Jan 2009
- Last updated
- 1 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-Controlled, Crossover Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 Compared to Placebo in the Treatment of Cancer Breakthrough Pain
- ClinicalTrials.gov ID
- NCT00833040
- Acronym / sponsor ID
- ARX-C-003
- Keywords
- Cancer breakthrough pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Talphera, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Posted 1 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 research study was to evaluate ARX-F02 (Sufentanil NanoTab) versus placebo ("sugar" pill or inactive substance) in the management of breakthrough pain in cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Titration of sufentanil, the DBL sufentanil & PBO | Experimental | Drug: Sublingual sufentanil NanoTabs™ and placebo NanoTabs™During the Titration Phase, patients titrated to the effective dosage of sublingual sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sublingual sufentanil NanoTab™ was taken as needed for breakthrough pain. During the Double-Blind Phase, patients were then randomized to one of six treatment sequences, each of which included seven active doses of sublingual sufentanil (dosage determined in Titration Phase) and three placebo doses taken in random order. One NanoTab™ was taken as needed for breakthrough pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients 18 years of age or older with documented clinical history or evidence of a malignancy.
- Patients must have sufficient pain to require at least the equivalent of 60 mg/day oral morphine, at least 25 mcg/hr transdermal fentanyl, at least 30 mg/day oxycodone, at least 8 mg/day oral hydromorphone for a week or longer.
- Patient is experiencing 1 - 4 episodes of cancer breakthrough pain per day, on average but not necessarily every day, requiring use of an additional opioid analgesic.
- Patient has a life expectancy of at least 3 months.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status rating < 2.
Key exclusion criteria (14 listed)
- Patients with uncontrollable or rapidly escalating pain.
- Patients with a history of psychiatric disease or loss of cognitive function that would prevent patient from providing reliable study documentation.
- Patients with oral mucositis or stomatitis.
- Patients with a history of substance abuse within the past year.
- Patients who are using intrathecal 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 |
|---|---|---|
| Sublingual sufentanil NanoTabs™ and placebo NanoTabs™Also: (ARX-F02)During the Titration Phase, patients titrated to the dose of sufentanil that provided adequate pain relief without intolerable side effects. Dosages were 20, 30, 40, 60 and 80 mcg. During the Double Blind Phase, patients were randomized to one of six sequences and took 7 doses of sufentanil (dosage determined in the titration phase, and 3 doses of placebo. | Drug | Titration of sufentanil, the DBL sufentanil & PBO |
Primary outcome
Time-weighted SPID30
Time frame: 30 minutes after dosing
time-weighted SPID30 is the sum of the pain intensity difference (PID) over the 30 minute time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is recorded at pre-dose, 10, 15, 30, 45, and 60 minutes post-dose. The pain score at each assessment time through 30 minutes is subtracted from the baseline pain score to provide the total sum score or SPID30. A higher SPID30 is better and indicates a reduction in pain intensity compared to the baseline score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
- 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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Cancer and Pain, run by Talphera, Inc at 13 sites 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 12 inclusion and 14 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 1 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 13 sites 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. 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 1 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?
Time-weighted SPID30 (time frame: 30 minutes after dosing). 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 1 Jan 2015.