Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation

NCT03523520

Constipation Drug Induced

COMPLETED PHASE4

A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV

NCT03657810

Pain Nausea Vomiting

COMPLETED PHASE3

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

NCT01438567

Pain Constipation

COMPLETED PHASE3

Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain

NCT01167127

Pain

COMPLETED PHASE3

A Study Comparing Oxycodone to Oxycodone/Naloxone in Moderate to Severe, Chronic Cancer Pain

NCT00513656

Cancer Pain Constipation

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Constipation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Active Hydromorphone PR + Active Naloxone PR

Optimal pain relief and improved bowel function in constipated pain patients

Intervention Type DRUG

Active Hydromorphone PR + Placebo Naloxone PR

Optimal pain relief and improved bowel function in constipated pain patients

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No