Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain

Constipation Clinical Trial

— HMX3501  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992576
• Other study ID #: 2008-005312-18
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 6, 2009
• Last updated: February 14, 2012
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: Mundipharma Research GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: AGESAustralia: TGA,Belgium: AFMPS;Czech Republic: SUKL,Denmark: DKMA,Finland: NAM,France: Afssaps,Germany: BfArM,Israel: MOH,Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: CEBK,Romania: NMA,Switzerland: FOPH,United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Active Hydromorphone PR + Active Naloxone PR
Optimal pain relief and improved bowel function in constipated pain patients
• Active Hydromorphone PR + Placebo Naloxone PR
Optimal pain relief and improved bowel function in constipated pain patients

Locations

Country	Name	City	State
Australia	Hunter New England Area Health Service	Newcastle	New South Wales
Austria	AKH Wien - Universitätskliniken	Wien
Belgium	Erasme Hospital	Bruxelles
Czech Republic	Poradna pro lecbu bolesti	Pribram
Denmark	Speciallæge Michael Crawford	København K.
Finland	Oma Lääkäri Oy	Kuopio
France	CHU - Hôpital Amiens Nord	Amiens Cedex 1
Germany	Universitaetsklinikum Jena	Jena
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Netherlands	Diakonessenhuis, locatie Zeist	Zeist
Poland	Szpital Uniwersytecki w Krakowie Zaklad Badania	Krakow
Romania	Spitalul Clinic Judetean de Urgenta Cluj	Cluj-Napoca
Switzerland	Kantonsspital Aarau	Aarau
United Kingdom	Avondale Surgery	Chesterfield

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research GmbH & Co KG

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel Function Measure Average pain scores
Secondary	Bowel Function Measures Rescue medication use