Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Official Title
A Randomized, Double-blind, Placebo and Active-controlled, Parallel-group Study to Evaluate the Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride Oral Fixed Combination on Moderate to Severe Acute Pain Following Abdominal Hysterectomy
Acronym
DAVID lap
Organization
Menarini GroupINDUSTRY
Status Module
Record Verification Date
Mar 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2013
Primary Completion Date
May 2014Actual
Completion Date
May 2014Actual
First Submitted Date
Jul 17, 2013
First Submission Date that Met QC Criteria
Jul 17, 2013
First Posted Date
Jul 22, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 9, 2015
Results First Submitted that Met QC Criteria
Mar 17, 2015
Results First Posted Date
Apr 1, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 4, 2016
Last Update Posted Date
Apr 1, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Menarini GroupINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only).
Approximately 600 female patients presenting moderate to severe pain after a total/subtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.
Detailed Description
In this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). Namely:
DKP/TRAM followed by DKP/TRAM;
DKP followed by DKP;
TRAM followed by TRAM;
placebo followed by DKP;
placebo followed by TRAM;
placebo followed by DKP/TRAM;
The analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
Conditions Module
Conditions
Acute Pain
Keywords
Moderate to severe acute pain
Postoperative pain
Abdominal hysterectomy
Analgesics
Dexketoprofen
Tramadol
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
606Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
DKP/TRAM followed by DKP/TRAM
Experimental
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
Drug: Dexketoprofen/Tramadol-single dose
Drug: Dexketoprofen/Tramadol-multiple doses
DKP followed by DKP
Active Comparator
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
Drug: Dexketoprofen-single dose
Drug: Dexketoprofen-multiple doses
TRAM followed by TRAM
Active Comparator
Tramadol-single dose followed by Tramadol-multiple doses
Drug: Tramadol-single dose
Drug: Tramadol-multiple doses
Placebo followed by DKP/TRAM
Other
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
Drug: Placebo
Drug: Dexketoprofen/Tramadol-multiple doses
Placebo followed by DKP
Other
Placebo single dose followed by Dexketoprofen-multiple doses
Drug: Placebo
Drug: Dexketoprofen-multiple doses
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Placebo single oral dose (first 8 hours)
Placebo followed by DKP
Placebo followed by DKP/TRAM
Placebo followed by TRAM
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
SPID8 (Sum of Pain Intensity Differences Over 8 Hours)
Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.
The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
over 8 hours after the first dose
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)
Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief - Verbal Rating Scale: pain relief 0=none, 4=complete) scores.
The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Female patients aged 18 to 75 years.
Scheduled to undergo a total or subtotal abdominal hysterectomy (with or without salpingo-oophorectomy) for benign conditions.
Patients experiencing pain at rest of at least moderate intensity the day after surgery.
Exclusion Criteria:
Patients not suitable for study treatments and rescue medication (RM) or those for whom non-steroidal anti-inflammatory drugs (NSAIDs), opioids, acetyl salicylic acid, pyrazolones or pyrazolidines are contraindicated.
Patients with clinically significant abnormalities in vital signs, safety laboratory tests and 12-lead ECG at screening.
Patients with history of any illness or condition that might pose a risk to the patient or confound the efficacy and safety study results.
Patients using and not suitable to withdraw analgesics other than those specified in the protocol.
Patients using and not suitable for withdrawing any of the prohibited medication specified in the protocol.
Breastfeeding women.
Accepts Healthy Volunteers
No
Sex
Female
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Henry J McQuay, Professor
Balliol College Oxford
Study Chair
Andrew Moore, Professor
Pain Research & Nuffield Department of Anaesthetics - University of Oxford
Moore RA, McQuay HJ, Tomaszewski J, Raba G, Tutunaru D, Lietuviete N, Galad J, Hagymasy L, Melka D, Kotarski J, Rechberger T, Fulesdi B, Nizzardo A, Guerrero-Bayon C, Cuadripani S, Piza-Vallespir B, Bertolotti M. Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy. BMC Anesthesiol. 2016 Jan 22;16:9. doi: 10.1186/s12871-016-0174-5.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
DKP/TRAM Followed by DKP/TRAM
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
FG001
DKP Followed by DKP
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Placebo followed by TRAM
Other
Placebo single dose followed by Tramadol-multiple doses
Drug: Placebo
Drug: Tramadol-multiple doses
Dexketoprofen-single dose
Drug
Dexketoprofen single oral dose (first 8 hours)
DKP followed by DKP
Tramadol-single dose
Drug
Tramadol single oral dose (first 8 hours)
TRAM followed by TRAM
Dexketoprofen/Tramadol-single dose
Drug
Dexketoprofen/Tramadol single oral dose (first 8 hours)
DKP/TRAM followed by DKP/TRAM
Dexketoprofen-multiple doses
Drug
Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses)
DKP followed by DKP
Placebo followed by DKP
Tramadol-multiple doses
Drug
Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
Placebo followed by TRAM
TRAM followed by TRAM
Dexketoprofen/Tramadol-multiple doses
Drug
Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
DKP/TRAM followed by DKP/TRAM
Placebo followed by DKP/TRAM
over 8 hours after first dose
SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)
Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.
PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.
The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
over 48 hours of the multiple-dose phase
Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)
Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS < 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable), over 48 hours of the multiple-dose phase.
The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
over 48 hours of the multiple-dose phase
Debrecen
H-4012
Hungary
Dr. Bugyi István Kórház
Szentes
H-6600
Hungary
Fejér megyei Szent György Kórház
Székesfehérvár
8000
Hungary
Juras Medicinas Centre
Riga
LV-1005
Latvia
Riga East University Hospital Gynecology Clinic
Riga
LV-1038
Latvia
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas
LT-50009
Lithuania
Vilniaus gimdymo namai
Vilnius
LT-02106
Lithuania
Samodzielny Publiczny Szpital Kliniczny nr 1
Lublin
Lublin Voivodeship
20-081
Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin
Lublin Voivodeship
20-954
Poland
Prywatna Klinika Polozniczo-Ginekologiczna
Bialystok
15-224
Poland
Ginekologiczno-Polożniczy Szpital Kliniczny UM w Poznaniu
Poznan
60-535
Poland
Wojewodzki Szpital
Przemyśl
37-700
Poland
Specjalistyczny Szpital im. E. Szczeklika
Tarnów
33-100
Poland
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Mini
Warsaw
00-909
Poland
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw
02-507
Poland
Institutul pentru Ocrotirea Mamei si Copilului (IOMC) "Prof. Dr. Alfred Rusescu"
Bucharest
011062
Romania
Genesys Fertility Center
Bucharest
011475
Romania
Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie II
Bucharest
020475
Romania
Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie I
Bucharest
020475
Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest
050098
Romania
Spitalul Clinic de Urgenta "Sfantul Pantelimon"
Bucharest
21623
Romania
Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Obstretica Ginecologie I
Târgu Mureş
540136
Romania
Moscow Regional Research Institute of Obstetrics and Gynecol
Tramadol-single dose followed by Tramadol-multiple doses
FG003
Placebo Followed by DKP/TRAM
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
FG004
Placebo Followed by DKP
Placebo single dose followed by Dexketoprofen-multiple doses
FG005
Placebo Followed by TRAM
Placebo single dose followed by Tramadol-multiple doses
FG000152 subjects
FG001151 subjects
FG002150 subjects
FG00351 subjects
FG00451 subjects
FG00551 subjects
Single-dose Phase
FG000152 subjects
FG001151 subjects
FG002150 subjects
FG00351 subjects
FG00451 subjects
FG00551 subjects
Multiple-dose Phase
FG000150 subjects
FG001146 subjects
FG002149 subjects
FG00348 subjects
FG00448 subjects
FG00549 subjects
COMPLETED
FG000147 subjects
FG001140 subjects
FG002148 subjects
FG00347 subjects
FG00446 subjects
FG00548 subjects
NOT COMPLETED
FG0005 subjects
FG00111 subjects
FG0022 subjects
FG0034 subjects
FG0045 subjects
FG0053 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0014 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0052 subjects
Lack of Efficacy
FG0000 subjects
FG0013 subjects
FG0021 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
non compliance with study drug
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Intention-to-treat (ITT) population (which includes all patients randomized).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
DKP/TRAM Followed by DKP/TRAM
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
BG001
DKP Followed by DKP
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
BG002
TRAM Followed by TRAM
Tramadol-single dose followed by Tramadol-multiple doses
BG003
Placebo Followed by DKP/TRAM
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
BG004
Placebo Followed by DKP
Placebo single dose followed by Dexketoprofen-multiple doses
BG005
Placebo Followed by TRAM
Placebo single dose followed by Tramadol-multiple doses
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000152
BG001151
BG002150
BG00351
BG00451
BG00551
BG006606
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00048.1± 6.70
BG00147.2± 7.07
BG00247.6± 6.87
BG003
Sex/Gender, Customized
Number
participants
Title
Denominators
Categories
Females
Title
Measurements
BG000152
BG001151
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG000152
BG001151
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Hungary
Title
Measurements
BG00022
BG00119
BG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00075.2± 15.15
BG00172.1± 13.54
BG002
Height
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000163.9± 5.40
BG001163.7± 6.37
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
SPID8 (Sum of Pain Intensity Differences Over 8 Hours)
Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.
The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
ITT population
Posted
Mean
Standard Deviation
units on a scale
over 8 hours after the first dose
ID
Title
Description
OG000
DKP/TRAM
Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
OG001
DEXKETOPROFEN
Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
OG002
TRAMADOL
Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
OG003
PLACEBO
Drug: Placebo single oral dose (first 8 hours) Arm type: Placebo comparator; Placebo single oral dose (first 8 hours)
Units
Counts
Participants
OG000152
OG001151
OG002150
OG003
Title
Denominators
Categories
Title
Measurements
OG000241.8± 139.06
OG001184.5± 139.23
OG002157.3± 150.89
OG003
Secondary
Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)
Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief - Verbal Rating Scale: pain relief 0=none, 4=complete) scores.
The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
ITT population
Posted
Number
percentage of participants
over 8 hours after first dose
ID
Title
Description
OG000
DKP/TRAM
Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
OG001
DEXKETOPROFEN
Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
OG002
TRAMADOL
Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
OG003
Secondary
SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)
Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.
PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.
The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
ITT population
Posted
Mean
Standard Deviation
units on a scale
over 48 hours of the multiple-dose phase
ID
Title
Description
OG000
DKP/TRAM
Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
OG001
DEXKETOPROFEN
Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 3 days (a total of 6 doses)
OG002
TRAMADOL
Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
Secondary
Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)
Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS < 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable), over 48 hours of the multiple-dose phase.
The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
ITT population
Posted
Number
percentage of participants
over 48 hours of the multiple-dose phase
ID
Title
Description
OG000
DKP/TRAM
Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
OG001
DEXKETOPROFEN
Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 3 days (a total of 6 doses)
OG002
TRAMADOL
Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
Time Frame
Study duration for patients was up to 6 weeks
Description
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
DKP/TRAM Followed by DKP/TRAM
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
7
151
22
151
EG001
DKP Followed by DKP
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
2
152
22
152
EG002
TRAM Followed by TRAM
Tramadol-single dose followed by Tramadol-multiple doses
1
150
33
150
EG003
Placebo Followed by DKP/TRAM
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
0
52
3
52
EG004
Placebo Followed by DKP
Placebo single dose followed by Dexketoprofen-multiple doses
0
50
10
50
EG005
Placebo Followed by TRAM
Placebo single dose followed by Tramadol-multiple doses
0
51
10
51
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0001 events1 affected151 at risk
EG0011 events1 affected152 at risk
EG0020 events0 affected150 at risk
EG0030 events0 affected52 at risk
EG004
Abdominal wound dehiscense
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected152 at risk
EG0020 events0 affected150 at risk
EG003
Anaemia postoperative
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected152 at risk
EG0020 events0 affected150 at risk
EG003
abdominal pain lower
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected152 at risk
EG0020 events0 affected150 at risk
EG003
diarrhoea
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected152 at risk
EG0020 events0 affected150 at risk
EG003
peritoneal haematoma
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected152 at risk
EG0020 events0 affected150 at risk
EG003
pneumonia
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected152 at risk
EG0020 events0 affected150 at risk
EG003
postoperative wound infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected152 at risk
EG0020 events0 affected150 at risk
EG003
Fallopian tube torsion
Reproductive system and breast disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected152 at risk
EG0021 events1 affected150 at risk
EG003
Ovarian torsion
Reproductive system and breast disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected152 at risk
EG0021 events1 affected150 at risk
EG003
Laparotomy
Surgical and medical procedures
MedDRA (15.1)
Non-systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected152 at risk
EG0021 events1 affected150 at risk
EG003
Pyrexia
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected152 at risk
EG0020 events0 affected150 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected152 at risk
EG0020 events0 affected150 at risk
EG003
Endometrial cancer stage I
Reproductive system and breast disorders
MedDRA (15.1)
Non-systematic Assessment
The investigator assessed the event as non serious. However, the event seriousness was upgraded by the sponsor as "other medically important condition".
EG0000 events0 affected151 at risk
EG0010 events0 affected152 at risk
EG0021 events1 affected150 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG00010 events9 affected151 at risk
EG0017 events6 affected152 at risk
EG00215 events14 affected150 at risk
EG0033 events3 affected52 at risk
EG0042 events2 affected50 at risk
EG0056 events5 affected51 at risk
Vomiting
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0005 events5 affected151 at risk
EG0016 events6 affected152 at risk
EG0028 events8 affected150 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0006 events6 affected151 at risk
EG0012 events2 affected152 at risk
EG0026 events6 affected150 at risk
EG003
Platelet count increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0003 events3 affected151 at risk
EG0018 events8 affected152 at risk
EG0029 events9 affected150 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0001 events1 affected151 at risk
EG0012 events2 affected152 at risk
EG0022 events2 affected150 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Prior to submitting the results of this study for publication or presentation, the PI will allow the Sponsor at least 60 days to review and comment upon the publication manuscript. The Sponsor will provide any manuscript of the results of this study at least 60 days before publishing to the authors for a complete review.
Point of Contact
Title
Organization
Phone
Extension
Email
Dr. Angela Capriati, Corporate Director of Clinical Research
Menarini Ricerche S.p.A.
+3905556809933
ACapriati@menarini-ricerche.it
ID
Term
D059787
Acute Pain
D010149
Pain, Postoperative
Ancestor Terms
ID
Term
D010146
Pain
D009461
Neurologic Manifestations
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
D011183
Postoperative Complications
D010335
Pathologic Processes
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C118296
dexketoprofen trometamol
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
3 subjects
FG0051 subjects
1 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
47.4
± 6.82
BG00447.4± 7.46
BG00547.2± 4.60
BG00647.6± 6.75
150
BG00351
BG00451
BG00551
BG006606
150
BG00351
BG00451
BG00551
BG006606
26
BG0038
BG0047
BG0057
BG00689
Slovakia
Title
Measurements
BG0007
BG00113
BG0028
BG0035
BG0042
BG0054
BG00639
Spain
Title
Measurements
BG0001
BG0012
BG0021
BG0030
BG0040
BG0051
BG0065
Poland
Title
Measurements
BG00063
BG00153
BG00260
BG00318
BG00423
BG00517
BG006234
Romania
Title
Measurements
BG00032
BG00140
BG00232
BG00310
BG00412
BG00512
BG006138
Lithuania
Title
Measurements
BG0002
BG0014
BG0023
BG0031
BG0041
BG0053
BG00614
Russian Federation
Title
Measurements
BG0003
BG0013
BG0023
BG0032
BG0042
BG0052
BG00615
Latvia
Title
Measurements
BG00022
BG00117
BG00217
BG0037
BG0044
BG0055
BG00672
71.3
± 12.17
BG00373.6± 13.74
BG00472.9± 14.60
BG00572.6± 10.97
BG00672.9± 13.58
164.1
± 6.10
BG003164.5± 6.17
BG004163.5± 5.94
BG005164.4± 5.59
BG006164.0± 5.94
153
117.0
± 121.80
PLACEBO
Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose during single dose phase (first 8 hours); Drug: Placebo single oral dose (first 8 hours) Arm type: placebo comparator; placebo single oral dose (first 8 hours)