Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain

A Confirmatory, Placebo-controlled, Randomised, Double-blind, Single-dummy, Parallel Group, Ratio-finding Study in Constipated Pain Patients to Establish an Optimal Hydromorphone - Naloxone Ratio With an Improved Bowel Function and a Comparable Analgesic Efficacy Compared to Hydromorphone Alone

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00992576

Acronym

HMX3501

Enrollment

600

Registered

2009-10-09

Start date

2010-01-31

Completion date

2012-01-31

Last updated

2012-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

Confirmatory, Constipation, Pain, Hydromorphone, Naloxone

Brief summary

The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.

Detailed description

Subjects suffering from cancer or non-cancer pain suffering from constipation cased or aggravated by opioids will be randomised to one of four ratios of hydromorphone PR plus naloxone PR or Hydromorphone PR plus placebo to investigate whether a hydromorphone/naloxone combination will lead to comparable analgesia, with a decrease in constipation, and to investigate the optimal dose ratio of hydromorphone and naloxone.

Interventions

DRUGActive Hydromorphone PR + Active Naloxone PR

Optimal pain relief and improved bowel function in constipated pain patients

DRUGActive Hydromorphone PR + Placebo Naloxone PR

Optimal pain relief and improved bowel function in constipated pain patients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or female subjects at least 18 years with a history of non-cancer or cancer pain that requires around-the-clock opioid therapy (8, 24 or 48 mg hydromorphone PR per day for the duration of the study). 2. Subjects with constipation caused or aggravated by opioids 3. Subjects must be willing to discontinue their current opioid analgesic routine, and . 4. current laxative regimen

Exclusion criteria

1. Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis. 2. Subjects presently taking, or who have taken, naloxone \<=30 days prior to the start of the Screening Period. 3. Subjects suffering from diarrhoea. 4. Abnormal liver or kidney function.

Design outcomes

Primary

Measure	Time frame
Bowel Function Measure Average pain scores	—

Secondary

Measure	Time frame
Bowel Function Measures Rescue medication use	—

Countries

Australia, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Israel, Netherlands, Poland, Romania, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026