Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients

NCT01014559 | Terminated Phase 3

• 2 other identifiers: OXN35052009-012051-20
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the reduction of the intensity of opioid-induced constipation symptoms in patients treated for cancer or non-cancer pain.

Conditions

Constipation; Pain

Keywords

Constipation; Oxycodone; Oxycodone hydrochloride; Naloxone hydrochloride; Naloxone

Outcome Measures

Primary Outcomes (1)

• Change of intensity of constipation symptoms, as assessed by the BFI from baseline to Day 28. The BFI is the mean value of 3 single items: Ease of defecation; Feeling of incomplete bowel evacuation; Personal judgement of constipation.

  28 days

Secondary Outcomes (1)

• Change of BFI from baseline (bl) to Days 7,14,21. Change of PAC-SYM score from bl to Days 7,14,21,28. Change of KESS score from bl to Days 7,14,21,28. Frequency of laxative medication use between Day 0 & Day 28. Change of pain as assessed by BPI-SF

  Days 7, 14 and 21

Study Arms (2)

Prolonged release tablet

ACTIVE COMPARATOR

OxyCodone Naloxone controlled release tablet

Drug: Oxycodone Naloxone

Tablet

ACTIVE COMPARATOR

Oxycodone PR Tablets

Drug: Oxycodone PR Tablets

Interventions

Oxycodone Naloxone DRUG

Oxycodone Naloxone PR Tablet taken twice daily

Prolonged release tablet

Oxycodone PR Tablets DRUG

Oxycodone PR Tablets taken twice daily

Tablet

Eligibility Criteria

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

You may qualify if:

• Male or female patient aged 18 years or older.
• With cancer pain or non-cancer pain such as chronic low back pain, osteoarthritis or other.
• Either currently receiving a WHO step II opioid and requiring the initiation of a WHO step III opioid (due to a lack of efficacy of the step II opioid) expected to last 28 days or more, or currently receiving a WHO step III opioid expected to last further 28 days or more.
• Having opioid-related constipation defined by either a KESS score ≥ 9 or the current use of laxatives (at least 3 times per week).
• Able, in the opinion of the Investigator, to comply with the study protocol.
• Having received oral and written information about the study protocol and signed a written, informed consent to participate.

You may not qualify if:

• Pregnancy or breastfeeding.
• Known contraindication or hypersensitivity to oxycodone, naloxone, bisacodyl, any chemically close substance, and ingredients.
• Clinically significant impairment of cardiovascular, respiratory, liver or kidney function disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that in the opinion of the Investigator may present a risk upon exposure to the study medication.
• Known or suspected unstable brain or spinal cord metastases that may require changes in steroid treatment throughout the duration of the study.
• Increased intracranial pressure.
• Evidence of clinically significant gastrointestinal disease (e.g., paralytic ileus, peritoneal carcinosis), significant structural abnormalities of the gastrointestinal tract (e.g., scarring, obstruction etc) either related or not related to the underlying cancer or disease progression.
• Rheumatoid arthritis, as co-medication may have an impact on the study results, especially if co-medication is not stable within the study.
• Surgery completed prior to the start of the study, or planned surgery during the study that would influence pain or bowel function during the study or preclude completion of the study.
• Radiotherapy that, in the investigators opinion, would influence bowel function or pain during the study.
• History of alcohol, opioid or other drug abuse.
• Current treatment with another psychoactive drug that, in the opinion of the Investigator, may present a risk when associated with an opioid.
• Any somatic or psychic condition that, in the opinion of the Investigator, may compromise the ability of the patient to understand and comply with the study protocol or to provide informed consent to participate.

Sponsors & Collaborators

• Mundipharma SAS: lead

Study Sites (1)

Hôpital Louis Pradel

Bron, 69500, France

Location

MeSH Terms

Conditions

Constipation; Pain

Interventions

oxycodone naloxone combination

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Design

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

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: February 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: February 1, 2013
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

FR (1)