A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

Purdue Pharma

Status and phase: Completed; Phase 3

Conditions: Low Back Pain

Treatments: Drug: Oxycodone/Naloxone controlled-release; Drug: Placebo; Drug: Oxycodone HCl controlled-release

Study type: Interventional

Funder types: Industry

Identifiers

NCT01427283

ONU3705

2011-005061-20 (EudraCT Number)

Details and patient eligibility

About

The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria include:

• Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period;
• The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation;
• Subjects must have a self-reported history of opioid induced constipation (OIC).

Exclusion Criteria include:

• Subjects with rheumatoid arthritis or other inflammatory arthritis;
• Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months;
• Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility;
• Subjects with chronic constipation not related to opioid use;
• Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study;
• Subjects with a history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated.

Other protocol specific inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 3 patient groups, including a placebo group

OXN

Experimental group

Description:

Oxycodone/Naloxone controlled-release tablets (OXN)

Treatment:

Drug: Oxycodone/Naloxone controlled-release

OXY

Active Comparator group

Description:

Oxycodone HCl controlled-release tablets (OXY)

Treatment:

Drug: Oxycodone HCl controlled-release

Placebo

Placebo Comparator group

Description:

Placebo tablets to match OXN or OXY

Treatment:

Drug: Placebo