A randomised, crossover study of study drug 038 and controlled-release oxycodone HCl tablets in patients with chronic non-cancer pai

Completed

Conditions: Chronic non-cancer pain and bowel function
Signs and Symptoms
Pain, not elsewhere classified

Registration Number: ISRCTN76170309

Lead Sponsor: Purdue Pharma Canada

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. Male or non-pregnant, non-nursing female patients over the age of 18 years with chronic non-cancer pain of moderate or greater intensity for at least three months
2. Patients who require stable doses of 60 to 80 mg every 12 hours of oxycodone or its analgesic equivalent
3. Patients experiencing less than three complete, spontaneous bowel movements in the seven days prior to randomisation

Exclusion Criteria

1. Patients who undergoing any treatments that may change their pain during the study, such as physiotherapy, corticosteroid injections or surgical procedures
2. Patients who do not respond adequately to doses of 60 or 80 mg every 12 hours of oxycodone
3. Patients whose pain is expected to be refractory to continuous opioid therapy
4. Patients with allergy to study drug 038, oxycodone or any other opioid
5. Patients with any of the following:
5.1. A condition that affects patient safety or obscures the assessment of efficacy
5.2. Compromised kidney or liver function
5.3. Risk for central nervous system (CNS) and/or respiratory depression
5.4. Significant gastrointestinal structural abnormalities or diseases/conditions that affect bowel function
5.5. A major psychiatric disorder
5.6. Received an investigational drug in the last month
5.7. Failed the urine drug screen

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity and bowel function measured during the last week of treatment in each phase.

Secondary Outcome Measures

Name	Time	Method
All assessments measured during the last week of treatment in each phase: <br>1. ROME-III<br>2. Patient Assessment of Constipation Symptoms (PAC-SYM)<br>3. Brief Pain Inventory<br>4. Multidimensional Pain Inventory<br>5. Beck Depression Inventory<br>6. Pain Disability Index<br>7. Pain and Sleep Questionnaire <br>8. Level of Activity