Back to resultsOxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain
Primary Purpose
Pain, Chronic Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Oxymorphone extended release
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Chronic pain, Extended Release, Long-Acting Opioid, Opioid, Opioid-Naive, Oxymorphone
Eligibility Criteria
Inclusion Criteria:
- Currently receive a stable non-opioid analgesic regimen
- Have an initial pain intensity score of greater than or equal to 40 mm on a 100-mm Visual Analogue Scale (VAS) and a categorical pain rating of moderate or severe on a categorical scale of none, mild, moderate, or severe
- If female, must be practicing abstinence or using a medically acceptable form of contraception
- Understand written and spoken English
- Have been informed of the nature of the study and provided written informed consent.
Exclusion Criteria:
- Positive pregnancy test (females only)
- History of or active asthma or emphysema
- Clinically significant hepatic impairment
Received any of the following medications within 48 hours prior to dosing:
- Dextromethorphan-containing medications (over-the-counter [OTC] cough and cold preparations, such as Vicks Formula 44)
- St. John's Wort >1000 mg/day
- Received monoamine oxidase inhibitor (MAOI) drugs within 2 weeks prior to dosing
Are not stabilized on the following medications for at least 4 weeks prior to dosing:
- Tricyclic antidepressant drugs
- Serotonin reuptake inhibitors
- Amphetamines used for attention-deficit/hyperactivity disorder (ADHD)
- History of alcohol or substance abuse within the last 3 years
- History of opioid abuse within 6 months prior to study entry
- Have a known oxymorphone sensitivity or allergy
- Have scheduled an elective surgery or procedure during the study that would not permit continuation of study medication, and/ or require another analgesic not currently taken by the patient
- Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication
- Have a known allergy or significant reaction to opioids
- Have been a participant in a previous oxymorphone clinical trial
- Have a history of seizure (Patients with a history of juvenile febrile seizures may be included if there has been no seizure history within the past 10 years).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Tolerability.
Secondary Outcome Measures
Average daily pain intensity (Question 5 of the Brief Pain Inventory [BPI] questionnaire) during the titration/stabilization period
Questions 3, 4, 5, 6, 8, and 9 of the BPI questionnaire
Average daily dose of oxymorphone ER
Rescue medication.
Total daily dose of oxymorphone ER and rescue medication
Time to stabilization. Patient/investigator global assessments
Treatment satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00911287
Brief Title
Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain
Official Title
An Open-Label Effectiveness and Safety Study of Oxymorphone Extended Release in Opioid-Naive Patients With Chronic Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Endo Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if oxymorphone ER is effective and safe in treating chronic pain in opioid-naive patients.
Detailed Description
The purpose of this study is to assess the effectiveness and tolerability of oxymorphone ER for the treatment of moderate to severe chronic pain in opioid-naive patients. Patients are gradually titrated from a 5mg dose of oxymorphone ER (taken every 12 hours) until stabilized dose is achieved. The study design is an open-label, nonrandomized 6-month study with a titration/stabilization period of ≤ 1 month followed by a 5-month maintenance period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Disease
Keywords
Chronic pain, Extended Release, Long-Acting Opioid, Opioid, Opioid-Naive, Oxymorphone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxymorphone extended release
Intervention Description
Study Medication: Oxymorphone ER 5 mg, 10 mg, and 20 mg tablets. Rescue Medication: Oxymorphone IR 5 mg tablets. Treatment will consist of up to 6 months of dosing with oxymorphone ER.
Primary Outcome Measure Information:
Title
Tolerability.
Time Frame
Entire study duration, including follow-up period.
Secondary Outcome Measure Information:
Title
Average daily pain intensity (Question 5 of the Brief Pain Inventory [BPI] questionnaire) during the titration/stabilization period
Time Frame
Week 1-4, Month 1-6
Title
Questions 3, 4, 5, 6, 8, and 9 of the BPI questionnaire
Time Frame
Week 1-4, Month 1-6
Title
Average daily dose of oxymorphone ER
Time Frame
Entire study duration
Title
Rescue medication.
Time Frame
Entire study duration
Title
Total daily dose of oxymorphone ER and rescue medication
Time Frame
Entire study duration
Title
Time to stabilization. Patient/investigator global assessments
Time Frame
Month 6
Title
Treatment satisfaction
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Currently receive a stable non-opioid analgesic regimen
Have an initial pain intensity score of greater than or equal to 40 mm on a 100-mm Visual Analogue Scale (VAS) and a categorical pain rating of moderate or severe on a categorical scale of none, mild, moderate, or severe
If female, must be practicing abstinence or using a medically acceptable form of contraception
Understand written and spoken English
Have been informed of the nature of the study and provided written informed consent.
Exclusion Criteria:
Positive pregnancy test (females only)
History of or active asthma or emphysema
Clinically significant hepatic impairment
Received any of the following medications within 48 hours prior to dosing:
Dextromethorphan-containing medications (over-the-counter [OTC] cough and cold preparations, such as Vicks Formula 44)
St. John's Wort >1000 mg/day
Received monoamine oxidase inhibitor (MAOI) drugs within 2 weeks prior to dosing
Are not stabilized on the following medications for at least 4 weeks prior to dosing:
Tricyclic antidepressant drugs
Serotonin reuptake inhibitors
Amphetamines used for attention-deficit/hyperactivity disorder (ADHD)
History of alcohol or substance abuse within the last 3 years
History of opioid abuse within 6 months prior to study entry
Have a known oxymorphone sensitivity or allergy
Have scheduled an elective surgery or procedure during the study that would not permit continuation of study medication, and/ or require another analgesic not currently taken by the patient
Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication
Have a known allergy or significant reaction to opioids
Have been a participant in a previous oxymorphone clinical trial
Have a history of seizure (Patients with a history of juvenile febrile seizures may be included if there has been no seizure history within the past 10 years).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Endo Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18950463
Citation
Fitzgerald JE, Simpson JA, Acheson AG. The use of intravenous iron in patients with cancer related anaemia: don't overlook iron deficiency anaemia in colorectal cancer. Br J Haematol. 2008 Dec;143(5):754; author reply 755. doi: 10.1111/j.1365-2141.2008.07415.x. No abstract available.
Results Reference
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Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain
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