Clinical trial NCT00992576: Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Constipation
Keywords: Confirmatory
Constipation
Pain
Hydromorphone
Naloxone
Lead sponsor: Mundipharma Research GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bowel Function Measure Average pain scores
Secondary outcomes:
measure: Bowel Function Measures Rescue medication use
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Hunter New England Area Health Service
state: New South Wales
city: Wien
country: Austria
facility: AKH Wien - Universitätskliniken
city: Bruxelles
country: Belgium
facility: Erasme Hospital
city: Pribram
country: Czech Republic
facility: Poradna pro lecbu bolesti
city: København K.
country: Denmark
facility: Speciallæge Michael Crawford
city: Kuopio
country: Finland
facility: Oma Lääkäri Oy
city: Amiens Cedex 1
country: France
facility: CHU - Hôpital Amiens Nord
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Zeist
country: Netherlands
facility: Diakonessenhuis, locatie Zeist
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie Zakład Badania
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Chesterfield
country: United Kingdom
facility: Avondale Surgery
Study officials:
References: