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

Pain Clinical Trial

Official title:

A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580294
• Other study ID #: GCO 07-0464
• Status: Completed
• Phase: N/A
• First received: December 19, 2007
• Last updated: January 4, 2016
• Start date: November 2007
• Est. completion date: August 2008

Study information

• Verified date: January 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:Non-ambulatory patients

• 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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Oxymorphone
IV PO

Locations

Country	Name	City	State
United States	Icahn School of Medcine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Erratum in: Pain Physician. 2011 Mar-Apr;14(2):217. Lin, Huong-Mo [corrected to Lin, Hung-Mo]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline and 12 hours	No
Primary	Brief Pain Inventory		Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment	No