HealthyPhase 4NCT01133873
Multiple-Ascending-Dose Study to Evaluate the Safety of Propoxyphene Napsylate In Healthy Adult Subjects
A Phase 4 study testing Propoxyphene napsylate (XP20C) in people with Healthy, run by Xanodyne Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to determine the daily maximum tolerated dose of propoxyphene napsylate in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Propoxyphene napsylate (XP20C)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Nov 2010
- Phase
- Phase 4
- 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 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index ≥ 18 and ≤ 30 (kg/m2)
- Medically healthy with normal screening results, or in the case of results that are abnormal; the abnormal results are clinically insignificant (eg, medical history, physical examination, neurological assessment, vital signs, oxygen saturation, laboratory profiles)
- 12-lead ECGs (calculations by the electrocardiograph) which have no clinically significant findings
- Vital signs which are within normal range
- No tobacco/nicotine-containing product use for a minimum of 6 months
- If female, must be able to adhere to acceptable methods of contraception or be postmenopausal or surgically sterile
Who cannot join
- History or presence of significant cardiovascular, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease
- History or presence of any degree of chronic obstructive pulmonary disease
- History of suicidal ideations or depression requiring professional intervention including counseling or antidepressant medication
- Any history of drug or alcohol abuse
- Positive drug (urine)/alcohol (breath) testing at screening or check-in
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV)
Show all 15Show fewer
- History of hypersensitivity or allergy to propoxyphene or any opioid compound, naloxone, naltrexone, palonosetron (Aloxi®), glycerin, senna, or bisacodyl (Dulcolax®)
- Use of any prescription medication (with the exception of hormonal contraceptives for females) within 2 weeks of enrollment
- Use of any over-the-counter medication, including herbal products, within 1 week of enrollment
- Use of any drugs known to significantly inhibit or induce liver enzymes involved in drug metabolism [CYP P450]) within 30 days of enrollment
- Blood donation or significant blood loss within 30 days of enrollment
- Plasma donation within 7 days of enrollment
- Participation in another clinical trial within 30 days of enrollment
- Females who are pregnant or lactating
- Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Lifetree Clinical Research
Salt Lake City, Utah, 84106
About this study
Official title: A Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled Study of Sequential Ascending Dose Levels to Assess the Safety, Tolerability and Electrocardiographic Effects of Propoxyphene Napsylate Capsules (and Its Metabolite Norpropoxyphene) When Administered Orally to Healthy Adult Subjects
The purpose of this study is to determine the daily maximum tolerated dose of propoxyphene napsylate in healthy subjects.
- Conditions
- Healthy
- Being tested
- Propoxyphene napsylate (XP20C), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propoxyphene napsylate (XP20C)Drug
Also called propoxyphene napsylate, Darvon-N, XP20C
100 mg capsules 6 times a day in ascending doses until a maximum tolerated dose is identified
PlaceboDrug
6 times a day in ascending doses until a maximum tolerated dose is identified
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Propoxyphene napsylate (XP20C) |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and tolerability of propoxyphene napsylate as determined by evaluation of adverse events, change from baseline of ventricular repolarization, lab results, and mental status
Measured: Day 13
Secondary outcomes (1)
Establish the relationship between serum concentrations of propoxyphene and norpropoxyphene on cardiac conduction and pharmacokinetic linearity of sequentially increased dose levels of propoxyphene napsylate.
Measured: Days -1, 1, 4, 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xanodyne Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lynn R Webster, MD, Principal investigator, Lifetree Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133873
- Sponsor's protocol ID
- XP20C-101
- Status last verified
- Apr 2011
- First submitted
- 24 May 2010
- Last updated
- 13 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled Study of Sequential Ascending Dose Levels to Assess the Safety, Tolerability and Electrocardiographic Effects of Propoxyphene Napsylate Capsules (and Its Metabolite Norpropoxyphene) When Administered Orally to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01133873
- Acronym / sponsor ID
- XP20C-101
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Xanodyne PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 31 May 2010 (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 this study is to determine the daily maximum tolerated dose of propoxyphene napsylate in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Propoxyphene napsylate (XP20C) |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body mass index ≥ 18 and ≤ 30 (kg/m2)
- Medically healthy with normal screening results, or in the case of results that are abnormal; the abnormal results are clinically insignificant (eg, medical history, physical examination, neurological assessment, vital signs, oxygen saturation, laboratory profiles)
- 12-lead ECGs (calculations by the electrocardiograph) which have no clinically significant findings
- Vital signs which are within normal range
- No tobacco/nicotine-containing product use for a minimum of 6 months
Key exclusion criteria (15 listed)
- History or presence of significant cardiovascular, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease
- History or presence of any degree of chronic obstructive pulmonary disease
- History of suicidal ideations or depression requiring professional intervention including counseling or antidepressant medication
- Any history of drug or alcohol abuse
- Positive drug (urine)/alcohol (breath) testing at screening or check-in
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 |
|---|---|---|
| Propoxyphene napsylate (XP20C)Also: propoxyphene napsylate, Darvon-N, XP20C100 mg capsules 6 times a day in ascending doses until a maximum tolerated dose is identified | Drug | 1 |
| Placebo6 times a day in ascending doses until a maximum tolerated dose is identified | Drug | 2 |
Primary outcome
Determine the safety and tolerability of propoxyphene napsylate as determined by evaluation of adverse events, change from baseline of ventricular repolarization, lab results, and mental status
Time frame: Day 13
1 secondary outcome
Establish the relationship between serum concentrations of propoxyphene and norpropoxyphene on cardiac conduction and pharmacokinetic linearity of sequentially increased dose levels of propoxyphene napsylate.
Time frame: Days -1, 1, 4, 11
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2011.
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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.
Lynn R Webster, MD principal investigator
Lifetree Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propoxyphene napsylate (XP20C) in people with Healthy, run by Xanodyne Pharmaceuticals 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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 13 Apr 2011. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early. Results are not available in the source record.
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?
Determine the safety and tolerability of propoxyphene napsylate as determined by evaluation of adverse events, change from baseline of ventricular repolarization, lab results, and mental status (time frame: Day 13). 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 13 Apr 2011.