Postoperative PainPhase 3NCT01082471
An Efficacy and Safety Study to Compare Morphine 6-glucuronide (M6G) and Morphine in Patients Suffering With Post-Operative Pain for at Least 24 Hours
A Phase 3 study testing Morphine 6-glucuronide and Morphine in people with Postoperative Pain, run by Paion UK Ltd. at 7 sites in 6 countries.
Trial summary
To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24 hour post-operative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Morphine 6-glucuronide and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 517 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Nov 2005to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients undergoing any of the following elective surgical procedures that, in the Investigator's opinion, would have required the use of post-operative patient controlled analgesia for a minimum of 24 hours:
- Abdominal hysterectomy with the exception of laparoscopic procedures.
- Bowel / gastrointestinal (GI) surgery
- Major urological surgery
- Aged ≥ 18 years
- American Society of Anesthesiologists (ASA) grades I to III
- If female, the patient had to be post-menopausal (last menstruation > 1 year previously), or surgically sterile (e.g. full hysterectomy or tubal ligation). If neither of these was the case, she had to use adequate contraception (i.e. hormonal contraceptive, intrauterine device (IUD), or a double barrier method) and to have a negative urine pregnancy test during the 24-hours prior to surgery.
- Provide written informed consent to participate in the trial prior to surgery.
Who cannot join
- The patient was pregnant or lactating.
- Had a known sensitivity to morphine or other opiates, or a medical condition such that opiates were contraindicated.
- Had a known sensitivity to paracetamol, or a medical condition such that paracetamol was contraindicated.
- Had received any investigational drug within the 90 days prior to the start of the study, or was scheduled to receive one during the study period.
- Had been involved in any previous M6G study.
- Had a documented history or current evidence of alcohol or drug abuse within the year prior to screening.
Show all 18Show fewer
- Had clinically significant findings on pre-treatment evaluations (e.g. laboratory results, electrocardiograms, medical history, physical examination) that, in the Investigator's opinion, should have excluded them from the study.
- Had a concurrent disorder that resulted in excessive pain that, in the Investigator's opinion, would have interfered with the pain assessments during the study (e.g.severe rheumatoid arthritis, muscle dystrophy or neuropathic pain).
- Had a blood clotting disorder or other blood dyscrasias.
- Had requested the use of epidural or intrathecal anaesthesia techniques.
- Required the use of a local anaesthetic block and/or infiltration of wound sites.
- Required the concomitant use of opioids or non-steroidal anti-inflammatory drugs(NSAIDs) during the study due to an existing concurrent condition.
- Had a history of Left Ventricular Failure or compromised cardiovascular function, defined as New York Heart Association (NYHA) level 3.
- Had a history of severe renal impairment or a creatinine level > 3 times the upper limit of normal.
- Was having surgery that would have prevented the use of oral or rectal paracetamol(iv administration of paracetamol was not allowed).
- Was expected to require prolonged ventilation after surgery.
- Was opioid tolerant or had a history of chronic opioid use.
- Had cognitive impairment that would, in the Investigator's opinion, have precluded participation or compliance with protocol defined procedures (i.e. use of PCA).
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
United Kingdom2 sites
Intensive Care Unit, Level 5, Western Infirmary,
Glasgow, Renfrewshire, G11 6NT
St John's Hospital
Livingston, West Lothian, EH54 6PP
France1 site
Anaesthetisia - Resuscitation Department, Tenon Hospital
Paris, Cedex 20, 75970
Germany1 site
Universitätsklinikum Bonn, Klinik und Poliklinik f. Anaesthesiologie
Bonn, 53105
Netherlands1 site
Department of Anaesthesiology, Leiden University Medical Centre
Leiden, 2300 RC
About this study
Official title: A Randomised Double-blind Study to Compare the Analgesic Efficacy and Safety Profiles of M6G and Morphine, as a Loading Dose Followed by PCA, in Patients Suffering Moderate to Severe Post-operative Pain Requiring PCA for at Least 24 Hours
To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24 hour post-operative period. Pain relief and nausea will be determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.
- Conditions
- Postoperative Pain
- Being tested
- Morphine 6-glucuronide, Morphine
- Keywords
- Morphine 6-glucuronide, Morphine, Patient Controlled Analgesia, Post Operative Nausea and Vomiting
- Medical subject headings
- Pain, Postoperative, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine 6-glucuronideDrug
MorphineDrug
| Study group | Role | What they receive |
|---|---|---|
| M6G | Experimental | An initial slow bolus injection up to 60 min prior to end of surgery. If required, two additional slow bolus injections to achieve baseline pain relief. Continuing on PCA for a minimum of 24 hours. Receives: Drug: Morphine 6-glucuronide |
| Morphine | Active comparator | An initial slow bolus injection up to 60 min prior to end of surgery. If required, two additional slow bolus injections to achieve baseline pain relief. Continuing on PCA for a minimum of 24 hours. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of nausea
To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24-hour post-operative period. Pain relief and nausea were determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.
Measured: The 6-18 hour period after titration to pain relief
Secondary outcomes (4)
Analgesic effect
To compare the analgesic effect of the study treatments using an Investigator- and patient-administered VRS-11 scale of pain intensity over the following time periods following achievement of baseline pain relief.
- 0-12 hours (AUCbaseline-12)
- 0-48 hours (AUCbaseline - 48)
- 12-24 hours (AUC12 - 24)
- 24-48 hours (AUC24 - 48) Pain levels will be compared using the AUC from baseline.
Measured: 0-48 hours after titration to pain relief
The incidence and severity of nausea
To compare the incidence and severity of nausea in the study treatment groups over the following time periods following achievement of baseline pain relief: 0-12 hours, 0-24 hours, 0-48 hours, 12-24 hours, 24-48 hours.
Measured: 0-48 hours
The incidence and severity of vomiting
To compare the incidence and severity of vomiting in the study treatment groups over the following time periods following achievement of baseline pain relief: 0-12 hours, 0-24 hours, 0-48 hours, 12-24 hours, 24-48 hours
Measured: 0-48 hours
The amounts of study drug required to achieve a baseline pain severity score of ≤ 3
To compare the amounts of study drug required to achieve a baseline pain severity score of ≤ 3
Measured: 60-30mins before close of surgery to time 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startNov 2005
- Primary completionNov 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paion UK Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chiltern International Ltd., HFL Ltd.
- Investigators
- Alexander Binning, M.D., Principal investigator, Intensive Care Unit, Level 5, Western Infirmary, Glasgow, G11 6NTJames Lees, B.Sc., Study director, Paion UK Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082471
- Sponsor's protocol ID
- M6G022
- Other IDs
- 2005-001690-99, 2005
- Status last verified
- Aug 2023
- First submitted
- 5 Mar 2010
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind Study to Compare the Analgesic Efficacy and Safety Profiles of M6G and Morphine, as a Loading Dose Followed by PCA, in Patients Suffering Moderate to Severe Post-operative Pain Requiring PCA for at Least 24 Hours
- ClinicalTrials.gov ID
- NCT01082471
- Acronym / sponsor ID
- M6G022
- Conditions
- Postoperative Pain
- Keywords
- Morphine 6-glucuronide, Morphine, Patient Controlled Analgesia, Post Operative Nausea and Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- Paion UK Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chiltern International Ltd., HFL Ltd.
- Study start
- Nov 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 8 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24 hour post-operative period. Pain relief and nausea will be determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M6G | Experimental | Drug: Morphine 6-glucuronideAn initial slow bolus injection up to 60 min prior to end of surgery. If required, two additional slow bolus injections to achieve baseline pain relief. Continuing on PCA for a minimum of 24 hours. |
| Morphine | Active comparator | Drug: MorphineAn initial slow bolus injection up to 60 min prior to end of surgery. If required, two additional slow bolus injections to achieve baseline pain relief. Continuing on PCA for a minimum of 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients undergoing any of the following elective surgical procedures that, in the Investigator's opinion, would have required the use of post-operative patient controlled analgesia for a minimum of 24 hours:
- Abdominal hysterectomy with the exception of laparoscopic procedures.
- Bowel / gastrointestinal (GI) surgery
- Major urological surgery
- Aged ≥ 18 years
Key exclusion criteria (18 listed)
- The patient was pregnant or lactating.
- Had a known sensitivity to morphine or other opiates, or a medical condition such that opiates were contraindicated.
- Had a known sensitivity to paracetamol, or a medical condition such that paracetamol was contraindicated.
- Had received any investigational drug within the 90 days prior to the start of the study, or was scheduled to receive one during the study period.
- Had been involved in any previous M6G study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine 6-glucuronide | Drug | M6G |
| Morphine | Drug | Morphine |
Primary outcome
Incidence and severity of nausea
Time frame: The 6-18 hour period after titration to pain relief
To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24-hour post-operative period. Pain relief and nausea were determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.
4 secondary outcomes
Analgesic effect
Time frame: 0-48 hours after titration to pain relief
The incidence and severity of nausea
Time frame: 0-48 hours
The incidence and severity of vomiting
Time frame: 0-48 hours
The amounts of study drug required to achieve a baseline pain severity score of ≤ 3
Time frame: 60-30mins before close of surgery to time 0.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
Related trials for Postoperative Pain
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Binning, M.D. principal investigator
Intensive Care Unit, Level 5, Western Infirmary, Glasgow, G11 6NT
James Lees, B.Sc. study director
Paion UK Ltd.
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Morphine 6-glucuronide and Morphine in people with Postoperative Pain, run by Paion UK Ltd. at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, Czechia, France, Germany, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of nausea (time frame: The 6-18 hour period after titration to pain relief). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.