A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy

NCT01438567 | Completed Phase 3

• 2 other identifiers: OXN35062010-021995-27
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The primary research objective is to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR tablets alone with cancer and non-cancer related pain without reducing the effectiveness of pain relief as measured by the Brief Pain Inventory (BPI).

Conditions

Pain; Constipation

Keywords

oxycodone naloxone combination; severe chronic and non-malignant pain; Malignant and non-malignant pain that requires around-the clock opioid therapy; Opioid related constipation

Outcome Measures

Primary Outcomes (1)

• Bowel function Index (BFI)

  To demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR

  5 weeks and a 6 month extension

Secondary Outcomes (1)

• Pain Intensity Scale (PIS)

  5 weeks

Study Arms (2)

OXN PR tablets

EXPERIMENTAL

Drug: oxycodone/naloxone prolonged release (OXN PR) tablets

OxyPR tablets

ACTIVE COMPARATOR

Drug: oxycodone prolonged release (OxyPR) tablets

Interventions

oxycodone/naloxone prolonged release (OXN PR) tablets DRUG

Drug: Oxycodone/naloxone prolonged release tablets Arms: OXN PR Dosage: 2x50/25mg daily or 2x60/30mg daily or 2x70/35mg daily or 2x80/40mg daily

OXN PR tablets

oxycodone prolonged release (OxyPR) tablets DRUG

Drug: Oxycodone prolonged release tablets Arms: OxyPR Dosage: 2x50mg daily or 2x60mg daily or 2x70mg daily or 2x80mg daily

OxyPR tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain.
• Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy

You may not qualify if:

• Females who are pregnant or lactating.
• Subjects with evidence or significant structural abnormalities of the gastrointestinal tract.
• Subjects with evidence of impaired liver/kidney function upon entry into the study.

Sponsors & Collaborators

• Mundipharma Research GmbH & Co KG: lead

Study Sites (1)

Ballygomartin Group Practice

Belfast, United Kingdom

Location

Related Links

• Results available on website

MeSH Terms

Conditions

Pain; Constipation; Bronchiolitis Obliterans Syndrome

Interventions

Oxycodone; Tablets

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: September 22, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

GB (1)