PainNCT00580294

A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)

A study testing Oxymorphone in people with Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain
What is being tested?: Oxymorphone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Nov 2007to Aug 2008
Phase: Interventional
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

Age of 18 to no upper limit
Chronic pain of nociceptive, neuropathic, or mixed origin
Patients with chronic non cancer pain
Ongoing chronic opioid treatment with either oral morphine or oxycodone (long term - more than 3 months of at least a total daily opioid dose of 60 mg morphine or of 30 mg oxycodone)
Pain of moderate intensity (>4, on the numerical scale 0-10) despite ongoing opioid therapy>
Non-pregnant, non-lactating women
Sufficient language skills to communicate with research staff

Who cannot join

Clinically significant respiratory, renal, hepatic, or cardiac disease.
Documented diagnosis of sleep apnea (the study physician may exclude patients who present with clinical features and complaints suggestive of a diagnosis of probable sleep apnea)
History of illicit drug or alcohol dependence or abuse, abnormal drug taking / seeking behaviors
Severe depression (> 26 on the BDI)
Patients who exhibit a score on the Mini Mental Status Exam (MMSE) of 26 or less. (The range of scores for mild dementia is 21-26 on the MMSE).
Workman compensation, current or pending medical-legal litigation
Hypersensitivity to study medication (oxymorphone)

Trial locations and contacts

1 site in 1 country.

United States1 site

Icahn School of Medcine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Official title: A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone

Conditions: Pain
Being tested: Oxymorphone
Keywords: Sciatica, Diabetic Neuropathies, Complex Regional Pain Syndromes, Low Back Pain, Neck Pain, Headache, Back Pain, Arthritis, Brachial Plexus Injury (stinger/burner), Chronic Pain, Contractures, Diabetes, Fibromyalgia, Foot Pain, Fracture, Hip, Herpes Zoster (shingles), Migraine, Neuropathic Pain, Osteoarthritis
Medical subject headings: Pain, Sciatica, Diabetic Neuropathies, Complex Regional Pain Syndromes, Low Back Pain, Neck Pain, Headache, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxymorphoneDrug
Also called Oxymorphone PO, Oxymorphone IV
IV PO

Study groups in NCT00580294
Study group	Role	What they receive
oxymorphone	Experimental	participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed Receives: Drug: Oxymorphone

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Patient Global Impression of Change
PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)
Measured: baseline and 12 hours
Brief Pain Inventory
Measured: Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Aug 2008

First posted24 Dec 2007 (estimated)
Study startNov 2007
Primary completionAug 2008
Study completionAug 2008

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 PainStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00580294
Sponsor's protocol ID: GCO 07-0464
Status last verified: Jan 2016
First submitted: 19 Dec 2007
Last updated: 3 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Korkmazsky M, Ghandehari J, Sanchez A, Lin HM, Pappagallo M. Feasibility study of rapid opioid rotation and titration. Pain Physician. 2011 Jan-Feb;14(1):71-82.
PubMed 21267044

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone
ClinicalTrials.gov ID: NCT00580294
Acronym / sponsor ID: GCO 07-0464
Conditions: Pain
Keywords: Sciatica, Diabetic Neuropathies, Complex Regional Pain Syndromes, Low Back Pain, Neck Pain, Headache, Back Pain, Arthritis
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Collaborators: Endo USA Inc., a Keenova Therapeutics Company
Study start: Nov 2007
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 24 Dec 2007 (estimated)
Results: Posted 3 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
oxymorphone	Experimental	Drug: Oxymorphoneparticipants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age of 18 to no upper limit
Chronic pain of nociceptive, neuropathic, or mixed origin
Patients with chronic non cancer pain
Ongoing chronic opioid treatment with either oral morphine or oxycodone (long term - more than 3 months of at least a total daily opioid dose of 60 mg morphine or of 30 mg oxycodone)
Pain of moderate intensity (>4, on the numerical scale 0-10) despite ongoing opioid therapy>

Key exclusion criteria (7 listed)

Clinically significant respiratory, renal, hepatic, or cardiac disease.
Documented diagnosis of sleep apnea (the study physician may exclude patients who present with clinical features and complaints suggestive of a diagnosis of probable sleep apnea)
History of illicit drug or alcohol dependence or abuse, abnormal drug taking / seeking behaviors
Severe depression (> 26 on the BDI)
Patients who exhibit a score on the Mini Mental Status Exam (MMSE) of 26 or less. (The range of scores for mild dementia is 21-26 on the MMSE).

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
OxymorphoneAlso: Oxymorphone PO, Oxymorphone IVIV PO	Drug	oxymorphone

Primary outcome

Change in Patient Global Impression of Change
Time frame: baseline and 12 hours
PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)
Brief Pain Inventory
Time frame: Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment

Results and safety

Results posted to the registry on 3 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxymorphone	12	12

Primary outcome: Change in Patient Global Impression of Change

Time frame: baseline and 12 hours. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Oxymorphone n = 12
Value	0.19 (0.08 to 0.44)

Primary outcome: Brief Pain Inventory

Time frame: Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment

The sponsor has not posted figures for this outcome.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxymorphone	0 of 12 (0%)	0 of 12 (0%)	Not reported

Limitations and caveats (from the sponsor): This was a pilot open-label study in a small number of participants. A larger randomized study with long-term follow-up and comparison to traditional protocols is necessary to affirm safety. (12 pts had 6 different chronic non-cancer pain diagnoses.)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21267044Korkmazsky M, Ghandehari J, Sanchez A, Lin HM, Pappagallo M. Feasibility study of rapid opioid rotation and titration. Pain Physician. 2011 Jan-Feb;14(1):71-82.

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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.

Marco Pappagallo, MD principal investigator

Icahn School of Medcine at Mount Sinai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Oxymorphone in people with Pain, run by Icahn School of Medicine at Mount Sinai 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 7 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 3 Feb 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2016). 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?

Change in Patient Global Impression of Change (time frame: baseline and 12 hours). The study lists 2 primary outcomes in all. 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 NCT00580294, 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 3 Feb 2016.