Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain

Phase 2

Completed

• Conditions: Constipation

• Registration Number: NCT00992576
• Lead Sponsor: Mundipharma Research GmbH & Co KG

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.

Study Timeline

• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Study Start: 2010-01
• Primary Completion: 2011-11
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-14
• Last Update Posted: 2012-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bowel Function Measure Average pain scores

Secondary Outcome Measures

Name	Time	Method
Bowel Function Measures Rescue medication use

Trial Locations

Locations (14)

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland

Hunter New England Area Health Service; 🇦🇺 Newcastle, New South Wales, Australia

Erasme Hospital; 🇧🇪 Bruxelles, Belgium

Poradna pro lecbu bolesti; 🇨🇿 Pribram, Czech Republic

Oma Lääkäri Oy; 🇫🇮 Kuopio, Finland

Avondale Surgery; 🇬🇧 Chesterfield, United Kingdom

Szpital Uniwersytecki w Krakowie Zakład Badania; 🇵🇱 Krakow, Poland

Diakonessenhuis, locatie Zeist; 🇳🇱 Zeist, Netherlands

Speciallæge Michael Crawford; 🇩🇰 København K., Denmark

CHU - Hôpital Amiens Nord; 🇫🇷 Amiens Cedex 1, France

Universitaetsklinikum Jena; 🇩🇪 Jena, Germany

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

AKH Wien - Universitätskliniken; 🇦🇹 Wien, Austria

Spitalul Clinic Judetean de Urgenta Cluj; 🇷🇴 Cluj-Napoca, Romania