HysterectomyPhase 3NCT00478023
A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy
A Phase 3 study testing Morphine and CG5503 IR in people with Hysterectomy and Postoperative, run by Grünenthal GmbH at 52 sites in 9 countries.
Trial summary
The main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR (tapentadol immediate release) compared to placebo in women undergoing abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Hysterectomy, Postoperative
- What is being tested?
- Morphine and CG5503 IR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 854 participants
- Where
- 52 sitesin 9 countries
- Study dates
- May 2007to Apr 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female between 18 and 80 years of age;
- Scheduled to undergo an abdominal hysterectomy with or without bilateral salpingo-oophorectomy due to uterine leiomyomas, or dysfunctional uterine bleeding or endometrial hyperplasia;
- Anesthesiological and surgical procedures performed according to protocol;
- Moderate or severe baseline pain following hysterectomy on a Verbal Rating Scale (VRS) within 6 hours following the last possible application of morphine subcutaneous;
- Pain following hysterectomy of at least 4 on an 11-point Numeric Rating Scale (NRS) within 6 hours following the last possible application of morphine subcutaneous;
- American Society of Anesthesiologists (ASA) classification I-III.
Who cannot join
- Vaginal hysterectomy;
- Ongoing or known history of painful endometriosis;
- Known or suspected chronic pelvic pain syndrome;
- Previous abdominal or pelvic open surgery;
- History of seizure disorder or epilepsy;
- History of alcohol or drug abuse;
Show all 12Show fewer
- Evidence of active infections that may spread to other areas of the body;
- severely impaired renal function, moderately or severely impaired hepatic function,
- Allergy or hypersensitivity to oxycodone, morphine, fentanyl hydromorphone, heparin, or any compound planned to be used during the anesthesia;
- Serious complication during surgery and up to randomization;
- Pre-operative use within 12hours prior to surgery or peri-operative use of non-steroidal anti-inflammatory drugs (NSAIDs);
- Treated regularly with opioid analgesic or non-steroidal anti-inflammatory drugs (NSAIDs) within 30 days prior to screening;
Trial locations and contacts
52 sites in 9 countries.
52 sites in 9 countries
Romania12 sites
Site 33
Brasov
Site 78
Brasov
Site 29
Bucharest
Site 30
Bucharest
Site 31
Bucharest
Site 32
Bucharest
Site 34
Bucharest
Site 35
Bucharest
Site 36
Bucharest
Site 76
Bucharest
Site 75
Craiova
Site 61
Ploieşti
Poland10 sites
Site 27
Katowice
Site 23
Krakow
Site 24
Lodz
Site 66
Lodz
Site 22
Lublin
Site 25
Lublin
Site 26
Ruda Śląska
Site 20
Warsaw
Site 21
Warsaw
Site 28
Wroclaw
Russia7 sites
Site 71
Belgorod
Site 37
Moscow
Site 38
Moscow
Site 44
Moscow
Site 73
Moscow
Site 42
Saint Petersburg
Site 43
Saint Petersburg
Slovakia5 sites
Site 48
Banská Bystrica
Site 51
Bratislava
Site 52
Bratislava
Site 62
Košice
Site 50
Martin
Ukraine5 sites
Site 64
Donetsk
Site 55
Kiev
Site 56
Kiev
Site 58
Kiev
Site 67
Zaporizhya
Hungary4 sites
Site 13
Békéscsaba
Site 14
Debrecen
Site 15
Komárom
Site 12
Nyíregyháza
Serbia4 sites
Site 45
Belgrade
Site 47
Belgrade
Site 46
Kragujevac
Site 70
Novi Sad
About this study
Official title: A Randomized, Double-blind, Parallel-arm, Placebo- and Comparator- Controlled Trial of the Efficacy and Safety of Multiple Doses of Immediate-release (IR) CG5503 for Postoperative Pain Following Abdominal Hysterectomy
The main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR (tapentadol immediate release) compared to placebo in women undergoing abdominal hysterectomy.
Read the detailed description
Subjects undergoing abdominal hysterectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. Tapentadol (CG5503), a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this study is to investigate the effectiveness (level of pain control) and safety (side effects) of 3 dose levels of CG5503 IR compared with no drug (placebo) or one dose level of morphine (an opioid commonly used to treat post-surgical pain). This study is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter study to evaluate the treatment of acute pain after abdominal hysterectomy. The study will include a blinded 72 hour in-patient phase immediately following hysterectomy, during which subjects will be treated with either 50-, 75-, or 100-mg CG5503 IR, a matched placebo, or 20-mg morphine, and pain relief will be periodically assessed. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR), and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and morphine. The alternative study hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 24 hours (using the mean SPID at 24 hours).
- Conditions
- Hysterectomy, Postoperative
- Being tested
- Morphine, CG5503 IR, Placebo
- Keywords
- Opioid, Central acting analgesic, Pain postoperative, Abdomen acute, CG5503 IR, Morphine, Placebo
- Medical subject headings
- Pain, Postoperative, Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
20 mg IR; 4 - 6 hourly; Total 72 hours
CG5503 IRDrug
Also called Tapentadol
50mg; 4 - 6 hourly; Total 72 hours
CG5503 IRDrug
Also called Tapentadol
75mg; 4 -6 hourly; Total 72 hours
CG5503 IRDrug
Also called Tapentadol
100mg, 4 - 6 hourly; Total 72 hours
PlaceboDrug
4 - 6 hourly; Total 72 hours
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Active comparator | Not described Receives: Drug: Morphine |
| Tapentadol 50 mg immediate release | Experimental | Not described Receives: Drug: CG5503 IR |
| Tapentadol 75 mg immediate release | Experimental | Not described Receives: Drug: CG5503 IR |
| Tapentadol 100 mg immediate release | Experimental | Not described Receives: Drug: CG5503 IR |
| Matched placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.
Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0).
Measured: Baseline to 24 hours after first intake of study drug
Secondary outcomes (1)
Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity
Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0).
Measured: Baseline value to 48 hours after first study drug intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HysterectomyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 854 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Tomasz Rechberger, Prof., Principal investigator, Samodzielny Publiczny Szpital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478023
- Sponsor's protocol ID
- 731200
- Status last verified
- Oct 2019
- First submitted
- 23 May 2007
- Last updated
- 28 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-arm, Placebo- and Comparator- Controlled Trial of the Efficacy and Safety of Multiple Doses of Immediate-release (IR) CG5503 for Postoperative Pain Following Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT00478023
- Acronym / sponsor ID
- 731200
- Conditions
- Hysterectomy, Postoperative
- Keywords
- Opioid, Central acting analgesic, Pain postoperative, Abdomen acute, CG5503 IR, Morphine, Placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 854 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study start
- May 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 24 May 2007 (estimated)
- Results
- Posted 27 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR (tapentadol immediate release) compared to placebo in women undergoing abdominal hysterectomy.
Detailed description
Subjects undergoing abdominal hysterectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. Tapentadol (CG5503), a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this study is to investigate the effectiveness (level of pain control) and safety (side effects) of 3 dose levels of CG5503 IR compared with no drug (placebo) or one dose level of morphine (an opioid commonly used to treat post-surgical pain). This study is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter study to evaluate the treatment of acute pain after abdominal hysterectomy. The study will include a blinded 72 hour in-patient phase immediately following hysterectomy, during which subjects will be treated with either 50-, 75-, or 100-mg CG5503 IR, a matched placebo, or 20-mg morphine, and pain relief will be periodically assessed. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR), and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and morphine. The alternative study hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 24 hours (using the mean SPID at 24 hours).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Morphine | Active comparator | Drug: Morphine |
| Tapentadol 50 mg immediate release | Experimental | Drug: CG5503 IR |
| Tapentadol 75 mg immediate release | Experimental | Drug: CG5503 IR |
| Tapentadol 100 mg immediate release | Experimental | Drug: CG5503 IR |
| Matched placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female between 18 and 80 years of age;
- Scheduled to undergo an abdominal hysterectomy with or without bilateral salpingo-oophorectomy due to uterine leiomyomas, or dysfunctional uterine bleeding or endometrial hyperplasia;
- Anesthesiological and surgical procedures performed according to protocol;
- Moderate or severe baseline pain following hysterectomy on a Verbal Rating Scale (VRS) within 6 hours following the last possible application of morphine subcutaneous;
- Pain following hysterectomy of at least 4 on an 11-point Numeric Rating Scale (NRS) within 6 hours following the last possible application of morphine subcutaneous;
Key exclusion criteria (12 listed)
- Vaginal hysterectomy;
- Ongoing or known history of painful endometriosis;
- Known or suspected chronic pelvic pain syndrome;
- Previous abdominal or pelvic open surgery;
- History of seizure disorder or epilepsy;
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 |
|---|---|---|
| Morphine20 mg IR; 4 - 6 hourly; Total 72 hours | Drug | Morphine |
| CG5503 IRAlso: Tapentadol50mg; 4 - 6 hourly; Total 72 hours | Drug | Tapentadol 50 mg immediate release |
| CG5503 IRAlso: Tapentadol75mg; 4 -6 hourly; Total 72 hours | Drug | Tapentadol 75 mg immediate release |
| CG5503 IRAlso: Tapentadol100mg, 4 - 6 hourly; Total 72 hours | Drug | Tapentadol 100 mg immediate release |
| Placebo4 - 6 hourly; Total 72 hours | Drug | Matched placebo |
Primary outcome
Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.
Time frame: Baseline to 24 hours after first intake of study drug
Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0).
1 secondary outcome
Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity
Time frame: Baseline value to 48 hours after first study drug intake.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hysterectomy
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Not yet recruiting
COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTS OF ULTRASOUND-GUIDED QUADRO-ILIAC PLANE AND TRANSVERSUS ABDOMINIS PLANE BLOCKS IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY
Postoperative Pain Following Total Laparoscopic Hysterectomy
Active, not recruitingPhase 2
Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy
Post Operative Analgesia
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Active, not recruiting
Clinical Assessment - HominisTM Surgical System
Hysterectomy
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.
Tomasz Rechberger, Prof. principal investigator
Samodzielny Publiczny Szpital
52 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Morphine and CG5503 IR in people with Hysterectomy and Postoperative, run by Grünenthal GmbH at 52 sites in 9 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 6 inclusion and 12 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 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Romania, Poland, Russia, Slovakia, Ukraine and 4 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 27 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. (time frame: Baseline to 24 hours after first intake of study drug). 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 28 Oct 2019.