A RANDOMISED, DOUBLE BLIND STUDY TO COMPARE THE ANALGESIC EFFICACY AND SAFETY PROFILES OF MORPHINE-6-GLUCURONIDE AND MORPHINE SULPHATE, GIVEN AS A LOADING DOSE FOLLOWED BY PATIENT-CONTROLLED ANALGESIA (PCA), IN PATIENTS SUFFERING MODERATE TO SEVERE POST-OPERATIVE PAIN REQUIRING PCA FOR AT LEAST 24 HOURS - N/A

• Conditions: Moderate to Severe Acute Post Operative Pain; Classification code 10036286

• Registration Number: EUCTR2005-001690-99-HU
• Lead Sponsor: CeNeS Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-28
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

Patients undergoing any of the following elective procedures that would be expected to require PCA for up to 48 hours (minimum 24 hours) for relief of moderate to severe post-operative pain.

1) Abdominal hysterectomy with the exception of laparoscopic procedures

2) Bowel / GI surgery

3) Major urological surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Pregnancy or lactation.

2) Known sensitivity to morphine or other opiates, or a medical condition
such that opiates are contraindicated.

3) Known sensitivity to paracetamol, or a medical condition such that paracetamol is contraindicated.

4) Blood clotting disorder or other blood dyscrasias.

5) History of Left Ventricular Failure or compromised cardiovascular function, defined as NYHA level 3.

6) History of severe renal impairment or a creatinine level >3 times the upper limit of normal.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified