Acute PainPhase 3DAVID-artNCT01902134
Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
A Phase 3 study testing Tramadol-single dose, Dexketoprofen-single dose and Dexketoprofen/Tramadol-single dose in people with Acute Pain, run by Menarini Group at 37 sites in 10 countries.
Trial 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 male and female patients presenting moderate to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Tramadol-single dose, Dexketoprofen-single dose and Dexketoprofen/Tramadol-single dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 641 participants
- Where
- 37 sitesin 10 countries
- Study dates
- Apr 2013to Feb 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 to 80 years. Females participating in the study must be either of non-childbearing potential, or willing to use a highly effective contraceptive method.
- Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to primary osteoarthritis.
- Patients experiencing pain at rest of at least moderate intensity the day after surgery.
Who cannot join
- 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.
- Pregnant and breastfeeding women.
Trial locations and contacts
37 sites in 10 countries.
37 sites in 10 countries
Poland6 sites
Uniwersytecki Szpital Klioniczny w Bialymstoku
Bialystok, 15-276
Warminskie Centrum Ortopedyczne
Elblag, 82-300
Medical University of Lodz
Lodz, Łódź Voivodeship, 91-002
Wojewodzki Szpital Specjalistyczny
Lublin, 20-718
Specjalistyczny Szpital im. E. Szczeklika
Tarnów, 33-100
Urazowo - Ortopedycznej Wojewodzkiego Szpitala Specjalistycznego we Wrocławiu
Wroclaw, 51-128
Czechia5 sites
Fakultni nemocnice Brno
Brno, 625 00
Urazova nemocnice v Brne
Brno, 662 50
Nemocnice Jihlava, p.o.
Jihlava, 586 33
Oblastni nemocnice Kladno
Kladno, 272 59
Oblastni nemocnice Mlada Boleslav a.s.
Mladá Boleslav, 293 50
Hungary5 sites
Uzsoki Hospital, Department of Orthopaedics
Budapest, 1145
University of Debrecen
Debrecen, H-4012
PTE KK Trauma Központ-Balesetsebészeti és Kézsebésze
Pécs, 7632
Fejér Megyei Szent György Kórház
Székesfehérvár, 8000
MÁV Kórház és Rendelőintézet, Ortopédiai osztály
Szolnok, 5000
Latvia4 sites
Liepaja Regional Hospital
Liepāja, LV-3414
Riga's 2nd Hospital
Riga, LV-1004
Hospital of Traumatology and Orthopaedics
Riga, LV-1005
Vidzemes Hospital
Valmiera, LV-4201
Lithuania4 sites
Kaunas Clinical Hospital
Kaunas, LT-44320
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, LT-50009
Klaipedos Universitetine ligonine
Klaipėda, 92288
Respublikine Vilniaus universitetine ligonine
Vilnius, LT-04130
Serbia4 sites
Clinical Center of Serbia
Belgrade, 11000
Institute for orthopedic Surgery Banjica [Ortopedic Surgery
Belgrade, 11000
Clinical Center Kragujevac
Kragujevac, 34000
Clinic for Orthopedic Surgery and Trauma Bul. Dr Zorana Djindjica
Niš, 18000
Ukraine4 sites
Cherkaska oblasna likarnia
Cherkasy, 18009
Instytut patologii khrebta ta suglobiv im. prof. M.I. Sytenka NAMN Ukraine
Kharkiv, 61024
Kyivska oblasna klinichna likarnia
Kyiv, 04107
Sevastopolska miska likarnia №9
Sevastopol, 99018
Spain2 sites
Hospital L'Esperança. Parc de Salut Mar.
Barcelona, 08024
Hospital Universitario Puerta del Mar
Cadiz, 11009
Taiwan2 sites
China Medical University Hospital [Orthopedic]
Taichung, 404
Kuang Tien General Hospital
Taichung, 433
About this study
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 After Elective Unilateral Total Hip Arthroplasty
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 male and female patients presenting moderate to severe pain after an elective primary hip arthroplasty are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.
Read the 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
- Acute Pain
- Being tested
- Placebo, Tramadol-single dose, Dexketoprofen-single dose, Dexketoprofen/Tramadol-single dose, Tramadol-multiple doses
- Keywords
- Moderate to severe acute pain, Postoperative pain, Hip arthroplasty, Analgesics, Dexketoprofen, Tramadol
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo single oral dose (first 8 hours)
Tramadol-single doseDrug
Tramadol single oral dose (first 8 hours)
Dexketoprofen-single doseDrug
Dexketoprofen single oral dose (first 8 hours)
Dexketoprofen/Tramadol-single doseDrug
Dexketoprofen/Tramadol oral single dose (first 8 hours)
Tramadol-multiple dosesDrug
Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)
Dexketoprofen-multiple dosesDrug
Dexketoprofen multiple oral doses t.i.d. for 5 days (total 12 doses)
Dexketoprofen/Tramadol-multiple dosesDrug
Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)
| Study group | Role | What they receive |
|---|---|---|
| DKP/TRAM followed by DKP/TRAM | Experimental | Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses Receives: Drug: Dexketoprofen/Tramadol-single dose; Drug: Dexketoprofen/Tramadol-multiple doses |
| DKP followed by DKP | Active comparator | Dexketoprofen-single dose followed by Dexketoprofen-multiple doses Receives: Drug: Dexketoprofen-single dose; Drug: Dexketoprofen-multiple doses |
| TRAM followed by TRAM | Active comparator | Tramadol-single dose followed by Tramadol-multiple doses Receives: Drug: Tramadol-single dose; Drug: Tramadol-multiple doses |
| Placebo followed by DKP/TRAM | Other | Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses Receives: Drug: Placebo; Drug: Dexketoprofen/Tramadol-multiple doses |
| Placebo followed by DKP | Other | Placebo single dose followed by Dexketoprofen-multiple doses Receives: Drug: Placebo; Drug: Dexketoprofen-multiple doses |
| Placebo followed by TRAM | Other | Placebo single dose followed by Tramadol-multiple doses Receives: Drug: Placebo; Drug: Tramadol-multiple doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over 8 hours after the first dose
Secondary outcomes (3)
SPID48 (Sum of Pain Intensity Differences Over First 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.
Measured: 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.
Measured: over 48 hours of the multiple-dose phase
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.
Measured: over 8 hours after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Moore, Professor, Study chair, Pain Research & Nuffield Department of Anaesthetics - University of OxfordHenry J McQuay, Professor, Study chair, Balliol College Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902134
- Sponsor's protocol ID
- DEX-TRA-05
- Other IDs
- 2012-004548-31
- Acronym
- DAVID-art
- Status last verified
- Feb 2016
- First submitted
- 15 Jul 2013
- Last updated
- 7 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McQuay HJ, Moore RA, Berta A, Gainutdinovs O, Fulesdi B, Porvaneckas N, Petronis S, Mitkovic M, Bucsi L, Samson L, Zegunis V, Ankin ML, Bertolotti M, Piza-Vallespir B, Cuadripani S, Contini MP, Nizzardo A. Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty. Br J Anaesth. 2016 Feb;116(2):269-76. doi: 10.1093/bja/aev457.
PubMed 26787797
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 After Elective Unilateral Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01902134
- Acronym / sponsor ID
- DAVID-art / DEX-TRA-05
- Conditions
- Acute Pain
- Keywords
- Moderate to severe acute pain, Postoperative pain, Hip arthroplasty, Analgesics, Dexketoprofen, Tramadol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- Menarini GroupIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Posted 1 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 male and female patients presenting moderate to severe pain after an elective primary hip arthroplasty 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| DKP/TRAM followed by DKP/TRAM | Experimental | Drug: Dexketoprofen/Tramadol-single dose, Drug: Dexketoprofen/Tramadol-multiple dosesDexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses |
| DKP followed by DKP | Active comparator | Drug: Dexketoprofen-single dose, Drug: Dexketoprofen-multiple dosesDexketoprofen-single dose followed by Dexketoprofen-multiple doses |
| TRAM followed by TRAM | Active comparator | Drug: Tramadol-single dose, Drug: Tramadol-multiple dosesTramadol-single dose followed by Tramadol-multiple doses |
| Placebo followed by DKP/TRAM | Other | Drug: Placebo, Drug: Dexketoprofen/Tramadol-multiple dosesPlacebo single dose followed by Dexketoprofen/Tramadol-multiple doses |
| Placebo followed by DKP | Other | Drug: Placebo, Drug: Dexketoprofen-multiple dosesPlacebo single dose followed by Dexketoprofen-multiple doses |
| Placebo followed by TRAM | Other | Drug: Placebo, Drug: Tramadol-multiple dosesPlacebo single dose followed by Tramadol-multiple doses |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients aged 18 to 80 years. Females participating in the study must be either of non-childbearing potential, or willing to use a highly effective contraceptive method.
- Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to primary osteoarthritis.
- Patients experiencing pain at rest of at least moderate intensity the day after surgery.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| PlaceboPlacebo single oral dose (first 8 hours) | Drug | Placebo followed by DKP, Placebo followed by DKP/TRAM, Placebo followed by TRAM |
| Tramadol-single doseTramadol single oral dose (first 8 hours) | Drug | TRAM followed by TRAM |
| Dexketoprofen-single doseDexketoprofen single oral dose (first 8 hours) | Drug | DKP followed by DKP |
| Dexketoprofen/Tramadol-single doseDexketoprofen/Tramadol oral single dose (first 8 hours) | Drug | DKP/TRAM followed by DKP/TRAM |
| Tramadol-multiple dosesTramadol multiple oral doses t.i.d. for 5 days (total 12 doses) | Drug | Placebo followed by TRAM, TRAM followed by TRAM |
| Dexketoprofen-multiple dosesDexketoprofen multiple oral doses t.i.d. for 5 days (total 12 doses) | Drug | DKP followed by DKP, Placebo followed by DKP |
| Dexketoprofen/Tramadol-multiple dosesDexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses) | Drug | DKP/TRAM followed by DKP/TRAM, Placebo followed by DKP/TRAM |
Primary outcome
SPID8 (Sum of Pain Intensity Differences Over 8 Hours)
Time frame: over 8 hours after the first dose
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.
3 secondary outcomes
SPID48 (Sum of Pain Intensity Differences Over First 48 Hours of the Multiple-dose Phase)
Time frame: over 48 hours of the multiple-dose phase
Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)
Time frame: over 48 hours of the multiple-dose phase
Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)
Time frame: over 8 hours after the first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26787797McQuay HJ, Moore RA, Berta A, Gainutdinovs O, Fulesdi B, Porvaneckas N, Petronis S, Mitkovic M, Bucsi L, Samson L, Zegunis V, Ankin ML, Bertolotti M, Piza-Vallespir B, Cuadripani S, Contini MP, Nizzardo A. Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty. Br J Anaesth. 2016 Feb;116(2):269-76. doi: 10.1093/bja/aev457.
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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.
Andrew Moore, Professor study chair
Pain Research & Nuffield Department of Anaesthetics - University of Oxford
Henry J McQuay, Professor study chair
Balliol College Oxford
37 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tramadol-single dose, Dexketoprofen-single dose and Dexketoprofen/Tramadol-single dose in people with Acute Pain, run by Menarini Group at 37 sites in 10 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 3 inclusion and 6 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 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Poland, Czechia, Hungary, Latvia, Lithuania and 5 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. 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 1 Apr 2015). 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?
SPID8 (Sum of Pain Intensity Differences Over 8 Hours) (time frame: over 8 hours after the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01902134, which also lists 1 linked publication.
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 7 Mar 2016.