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Oxycodone-naloxone in Relieving Opioid-related Constipation

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Mundipharma

Status and phase

Completed
Phase 3

Conditions

Pain

Treatments

Drug: Oxycodone nalaxone prolonged release tablets (OXN)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00412152
2005-002398-57 (EudraCT Number)
OXN3001

Details and patient eligibility

About

The primary objective of this study is to demonstrate that subjects with moderate to severe non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Full description

Patients with a documented history of moderate to severe non-malignant pain that require around the clock opioid therapy will be randomised to an oxycodone or an oxycodone-naloxone treatment arm to assess the safety and efficacy of oxycodone/naloxone prolonged release compared to oxycodone prolonged-release in relieving opioid-related constipation.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female subjects at lest 18 years or older with pain.
  • Subjects must report constipation caused or aggravated by opioids.

Exclusion criteria

  • Females who are pregnant or lactating.
  • Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract (e.g. bowel obstruction, strictures).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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