Multiple-Ascending-Dose Study to Evaluate the Safety of Propoxyphene Napsylate In Healthy Adult Subjects
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ClinicalTrials.gov Identifier: NCT01133873 |
Recruitment Status
:
Terminated
First Posted
: May 31, 2010
Last Update Posted
: April 13, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Propoxyphene napsylate (XP20C) Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Propoxyphene napsylate (XP20C)
100 mg capsules 6 times a day in ascending doses until a maximum tolerated dose is identified
Other Names:
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Placebo Comparator: 2 |
Drug: Placebo
6 times a day in ascending doses until a maximum tolerated dose is identified
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133873
United States, Utah | |
Lifetree Clinical Research | |
Salt Lake City, Utah, United States, 84106 |
Principal Investigator: | Lynn R Webster, MD | Lifetree Clinical Research |
Responsible Party: | Gary Shangold, MD / Chief Medical Officer, Xanodyne Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01133873 History of Changes |
Other Study ID Numbers: |
XP20C-101 |
First Posted: | May 31, 2010 Key Record Dates |
Last Update Posted: | April 13, 2011 |
Last Verified: | April 2011 |
Additional relevant MeSH terms:
Dextropropoxyphene Levopropoxyphene Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Antitussive Agents Respiratory System Agents |