NCT00930943

Brief Summary

The purpose of the study is to determine whether extended-release oxymorphone hydrochloride taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB) tests, to a greater extent than when taking under conditions of fasting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_4 chronic-pain

Timeline
Completed

Started May 2009

Shorter than P25 for phase_4 chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
13.5 years until next milestone

Results Posted

Study results publicly available

May 9, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

June 29, 2009

Results QC Date

April 19, 2012

Last Update Submit

May 8, 2023

Conditions

Chronic Pain

Keywords

opioid tolerantchronic pain

Outcome Measures

Primary Outcomes (2)

  • Rapid Visual Information Processing (RVP) Sensitivity [A']

    RVP is a test of sustained attention. It is a sensitive measure of general cognitive performance. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudorandom order, at the rate of 100 digits per minute. The subject is requested to detect target sequences of three digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the response box. The two main outcome measures are the probability to detect the predefined sequence (sensitivity \[A'\]) and the speed at which the sequence is registered (response latency \[ms\]).

    1 and 3 hours postdose

  • Rapid Visual Information Processing (RVP) Response Latency

    RVP is a test of sustained attention. It is a sensitive measure of general cognitive performance. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudorandom order, at the rate of 100 digits per minute. The subject is requested to detect target sequences of three digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the response box. The two main outcome measures are the probability to detect the predefined sequence (sensitivity \[A'\]) and the speed at which the sequence is registered (response latency \[ms\]).

    1 and 3 hours postdose

Secondary Outcomes (4)

  • Spatial Recognition Memory (SRM) Test Percentage of Correct Hits

    1 and 3 hours postdose

  • Spatial Recognition Memory (SRM) Test Response Latency

    1 and 3 hours postdose

  • Spatial Working Memory (SWM) Test Total Errors

    1 and 3 hours postdose

  • Spatial Working Memory (SWM) Test Strategy Score

    1 and 3 hours postdose

Study Arms (2)

Oxymorphone ER 40 mg fed

EXPERIMENTAL

Participants received 40 mg oxymorphone ER after a high-fat meal of approximately 1,010 kCal

Drug: Oxymorphone ER

Oxymorphone ER 40 mg fasting

EXPERIMENTAL

Participants received 40 mg oxymorphone ER after fasting for 8-12 hours

Drug: Oxymorphone ER

Interventions

Oxymorphone ERDRUG

40 mg qd twice

Also known as: Opana ER
Oxymorphone ER 40 mg fastingOxymorphone ER 40 mg fed

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man or woman, 18-65 years of age, inclusive
  • Able to provide informed consent and comply with all study procedures
  • Women of childbearing potential with a negative urine pregnancy test at screening and on adequate contraception
  • Chronic, non-malignant, painful condition, treated with long-acting opioid (methadone, OxyContin®, MS (Morphine Sulfate) Contin®, Kadian®, Avinza®, Fentanyl®, Opana® ER)
  • Opioid treatment for at least 3 months prior to screening at a minimum dose of 90 mg of morphine equivalents per day or 50 mcg of the fentanyl transdermal patch
  • Dose of opioid treatment stable for at least 1 week prior to screening and expected to be stable from screening through end of second testing
  • Weight at screening 100-300 pounds, inclusive

You may not qualify if:

  • Pregnant or breastfeeding
  • Gastrointestinal disorder or S/P gastrointestinal surgery impacting absorption of study medication (delayed gastric emptying, partial or complete gastrectomy)
  • Alcohol or substance abuse within 2 years of screening
  • Consumption of alcohol within 24 hours of a screening or testing visit
  • Consumption of xanthine-containing beverages (coffee, tea, coke) on the morning of a screening or testing visit
  • Impaired kidney or liver function (transaminase levels more than 3 times elevated; estimated creatinine clearance less than 50 mL/min)
  • Epworth sleepiness scale (ESS) score 16 or higher at screening
  • Medically concerning hypertension (≥ 160/100) or unstable cardiovascular illness
  • Any clinically significant illness that would interfere with study participation or put the subject at risk
  • Exposure to investigational medication within 30 days of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedVadis Research Corporation

Wellesley Hills, Massachusetts, 02481, United States

Location

Related Publications (1)

  • Spierings EL, Volkerts ER, Heitland I, Thomson H. A randomized, rater-blinded, crossover study of the effects of oxymorphone extended release, fed versus fasting, on cognitive performance as tested with CANTAB in opioid-tolerant subjects. Pain Med. 2014 Feb;15(2):264-71. doi: 10.1111/pme.12307. Epub 2013 Dec 11.

    PMID: 24330343RESULT

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Egilius L.H. Spierings, M.D., Ph.D.
Organization
MedVadis Research Corporation
Spierings@MedVadis.com
781-588-5430

Study Officials

  • Egilius LH Spierings, MD, PhD

    MedVadis Research Corporation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2009

First Posted

July 2, 2009

Study Start

May 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

May 9, 2023

Results First Posted

May 9, 2023

Record last verified: 2023-05

Locations

US(1)