Pain ManagementPhase 4NCT03472339
Clinical Trial Comparing Intravenous and Oral Diclofenac and Pharmacokinetics
A Phase 4 study testing Diclofenac Sodium in people with Pain Management and Limb Injury, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
NSAIDs are commonly used in the management of acute pain; Diclofenac is one from the same class. It is an amino phenyl acetic acid derivative which inhibits prostaglandin biosynthesis to produce analgesic, antipyretic and anti-inflammatory effect. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Limb Injury
- What is being tested?
- Diclofenac Sodium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteQatar
- Study dates
- 15 Jan 2018to 15 Apr 2018
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Adult patients above 18-65 years of age.
- Patients with soft tissue injury/ cut wounds
- Pain score more than or equal to 4 on NRS.
- Patients weight more than or equal to 50kgs.
- If treating physician approves patient participation in the study.
- Not on any medication.
Who cannot join
- Received any analgesic within last 12 hours, on the day of visit to ED.
- Patients with fractures
- Allergic to diclofenac.
- Cardio-vascular disease, renal impairment, stroke or any other co-morbidity / chronic illness.
- Pregnancy / Nursing
- Peptic ulcers
Show all 9Show fewer
- Bleeding disorders
- liver disease
- Bronchial asthma
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Isma Qureshi
Doha, 3050
Isma Qureshi, 44390985, iqureshi@hamad.qa
Isma Qureshi, MBBS
About this study
Official title: A Randomized Double-blinded Trial Comparing the Clinical Efficacy and Pharmacokinetic Parameters of Oral Diclofenac and Intramuscular Diclofenac in Patients With Acute Limb Injuries
NSAIDs are commonly used in the management of acute pain; Diclofenac is one from the same class. It is an amino phenyl acetic acid derivative which inhibits prostaglandin biosynthesis to produce analgesic, antipyretic and anti-inflammatory effect. The drug efficacy and safety in acute pain management has been proved by several studies like in renal colic, post and pre-operative pain management, migraines etc. It's also known to have an opioid-sparing effect. Mode of administration is one of the important factors to consider in a busy emergency room. Perception about the route of administration differs among patients. As believed,injectable have rapid onset, easier to titrate, and patients respond better to them as they consider them stronger than oral medication. Number of trials has compared oral and parenteral NSAIDs. Most found no benefit to the parenteral route. Considering the limitations of the previously done studies like small sample size, heterogeneity in the group of patients enrolled, improper blinding and comparing of two different drugs from the same class. Therefore, aim of the study is to conduct a Double blind randomized clinical trial to assess the clinical efficacy and pharmacokinetic parameters of oral diclofenac compared to intramuscular diclofenac in patients with acute limb injury.
In this two group double blind randomized clinical trial, the clinical efficacy and pharmacokinetic parameters among the two groups will be assessed. Eligible patients visiting to HGH-ED, age (above 18 years) with acute limb injury, having moderate to severe pain (defined as pain score of >=4 on Numerical rating scale) will be recruited. With the use of computer generated block randomization, subjects will be allocated to one of the two treatment groups in the ratio of 1:1. Each group will receive either (intramuscular diclofenac / oral placebo) or (oral diclofenac / intramuscular placebo). Among the 300 subjects enrolled for the study, further stratified randomization will be done in order to enroll 20 patients for pharmacokinetic study within the subjects.High-performance liquid chromatography, method will be used for the determination of drug concentration in human plasma, for detailed pharmacokinetics. The pain score will be assessed by using the validated pain scale i.e. Numerical rating scale (NRS). The participants, clinicians and investigators will be masked to treatment assigned and the results will be analyzed by the intention to treat analysis among the two group treatment.
Read the detailed description
This will be a prospective, double blinded, randomized clinical trial, and it will be conducted and reported according to the consolidated standards of reporting trials group 14.
Setting:
The study will be conducted at Hamad General Hospital Emergency Department (HGH-ED). Since it is the largest tertiary care medical center in the country, having a busy ED with monthly census exceeding 40,000 (approximately 500,000 annually). Patients with acute limb injury are frequently seen in ED.
Sample size calculation:
300 patients are required to have a 95% chance of detecting, as significant at the 5%level, a decrease in the primary outcome measure from 70% in the control group to 50% in the experimental group. As for the number of subjects to be enrolled in pharmacokinetic study is directly related to both power and cost of the trial (14)*, we aim a convenience sample of 20 subjects, 10 in each group.
Screening and Randomization:
All adult patients (age above 18-65 years) presenting with Acute limb injury will be assessed by the available physician initially. Patient's hospital identification number will be put into the study registry. The registry will assure all consecutive patients are screened. Once an eligible patient is identified the physicians will page the research assistant, who will be available in the emergency department from 6 am to 2 pm on week days. After meeting the inclusion criteria and the subject agrees to participate, written consent will be obtained. The enrolled participants will be randomly assigned in a 1:1 ratio, to one of the two groups- either intramuscular diclofenac or oral diclofenac, from the trial packet available in the stock.
A computer generated block randomization sequence will be generated and stored with sequential coding known to the clinical pharmacist only. Within the randomized sequence, another stratified randomized sequence will be generated for the 20 subjects to be enrolled for pharmacokinetic trial only during the morning shifts. In case of adverse reaction form will be filled and medical research center will be notified for such event.
Intervention:
Typical trial packet
- Syringe A: 3ml solution, diclofenac 75mg or placebo
- Tablet: 100mg diclofenac tablet or placebo A trial packet will contain one syringe labelled A (3ml) and one tablet labelled B (100mg) in an amber colored zip lock pouch. Each will be labelled with a sticker mentioning a unique code, date of preparation and instructions for administration.
Trial packs A B Combination 1 Intramuscular Diclofenac Oral Placebo Combination 2 Oral Diclofenac Intramuscular Placebo Trial packs will be prepared and kept in a locker ready to be used on a daily basis. The team preparing these packets will have no further part in patient treatment or data recording.
Dosage
- Intramuscular Diclofenac will be available in 75mg/3ml concentration for single dose intramuscular administration.
- Tablet Diclofenac will be available as 100mg tablet for single dose per oral administration.
The protocol dictates to administer syringe "A" (3ml) intramuscular, 100mg tablet labeled "B" to administer per oral.
Data and sample collection:
Patient enrolled for pharmacokinetic measurement, will have an intravenous line to obtain blood for routine sampling, a hep- lock will be attached to the line, for the withdrawal of repeated samples. Blood samples will be collected only in weekdays and morning shifts from 6am until 2 pm. 3 ml of blood will be withdrawn at time 0, 5, 10, 15, 20, 25, 30, 45 and 60 minutes. High- performance liquid chromatography method will be used to determine drug in human plasma as the method is potentially considered to be used for detailed pharmacokinetics, pharmacodynamics and bioequivalence studies of diclofenac in humans. Along with blood sampling patient pain score using a numerical rating scale (NRS) will be used to assess the pain, as for the rest of the patients. Pain scores will be recorded at 0, 5, 10, 15, 20, 25, 30, 45 and 60, minutes following administration of analgesia. Patients reported pain scores will be recorded contemporaneously and patient will not be reminded of the previous score. If patients pain does not reduce significantly at the end of 30 minutes after receiving the study drug, a rescue analgesia in the form of morphine will be given 3mg intravenously every 5 minutes until sedation side effects or pain drops to Numerical rating score = or <2.Patient will be discharged as per the advice of the available physician in ED.
- Conditions
- Pain Management, Limb Injury
- Being tested
- Diclofenac Sodium
- Keywords
- Acute limb injury, Diclofenac, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac SodiumDrug
Group A-Intramuscular diclofenac sodium+oral placebo Group B-Oral diclofenac sodium+ intramuscular placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | diclofenac sodium75 mg, intravenously, once Receives: Drug: Diclofenac Sodium |
| Group B | Active comparator | diclofenac sodium 100 mg, orally, once Receives: Drug: Diclofenac Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportion of patients achieving 50% pain reduction
The primary outcome is defined as the proportion of patients achieving pain reduction by 50% at 30 minutes following analgesia administration.
Measured: 30 mins
the mean difference in plasma concentration for two drugs
Cmax - Peak plasma concentration and Time curve
Measured: 60 mins
Secondary outcomes (3)
proportion of patients achieving pain reduction of >=2 Numerical Rating Scale( which is a numeric scale where respondent selects a whole number from 0 to 10, where 0 means no pain and 10 means worst pain) from the initial score
to assess proportion of patients who could achieve minimal significant pain reduction
Measured: at 30 mins
Rescue analgesia
proportion of patients requiring a rescue analgesia after 30 min in each group
Measured: after 30 mins
Adverse events
the number of adverse events in each group
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start15 Jan 2018
- Primary completion15 Apr 2018 (estimated)
- Study completion15 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Isma Qureshi, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472339
- Sponsor's protocol ID
- 16413/16
- Status last verified
- Mar 2018
- First submitted
- 1 Mar 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Derry P, Derry S, Moore RA, McQuay HJ. Single dose oral diclofenac for acute postoperative pain in adults. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004768. doi: 10.1002/14651858.CD004768.pub2.
PubMed 19370609Marret E, Kurdi O, Zufferey P, Bonnet F. Effects of nonsteroidal antiinflammatory drugs on patient-controlled analgesia morphine side effects: meta-analysis of randomized controlled trials. Anesthesiology. 2005 Jun;102(6):1249-60. doi: 10.1097/00000542-200506000-00027.
PubMed 15915040Pathan SA, Mitra B, Straney LD, Afzal MS, Anjum S, Shukla D, Morley K, Al Hilli SA, Al Rumaihi K, Thomas SH, Cameron PA. Delivering safe and effective analgesia for management of renal colic in the emergency department: a double-blind, multigroup, randomised controlled trial. Lancet. 2016 May 14;387(10032):1999-2007. doi: 10.1016/S0140-6736(16)00652-8. Epub 2016 Mar 16.
PubMed 26993881Gan TJ, Daniels SE, Singla N, Hamilton DA, Carr DB. A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study. Anesth Analg. 2012 Nov;115(5):1212-20. doi: 10.1213/ANE.0b013e3182691bf9. Epub 2012 Aug 10.
PubMed 22886837Turturro MA, Paris PM, Seaberg DC. Intramuscular ketorolac versus oral ibuprofen in acute musculoskeletal pain. Ann Emerg Med. 1995 Aug;26(2):117-20. doi: 10.1016/s0196-0644(95)70138-9.
PubMed 7618770Ucar R, Biyik M, Ucar E, Polat I, Cifci S, Ataseven H, Demir A. Rectal or intramuscular diclofenac reduces the incidence of pancreatitis afterendoscopic retrograde cholangiopancreatography. Turk J Med Sci. 2016 Jun 23;46(4):1059-63. doi: 10.3906/sag-1502-104.
PubMed 27513404
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blinded Trial Comparing the Clinical Efficacy and Pharmacokinetic Parameters of Oral Diclofenac and Intramuscular Diclofenac in Patients With Acute Limb Injuries
- ClinicalTrials.gov ID
- NCT03472339
- Acronym / sponsor ID
- 16413/16
- Conditions
- Pain Management, Limb Injury
- Keywords
- Acute limb injury, Diclofenac, pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Apr 2018 (estimated)
- Study completion
- 15 Apr 2018 (estimated)
- First posted
- 21 Mar 2018 (actual)
- 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.
NSAIDs are commonly used in the management of acute pain; Diclofenac is one from the same class. It is an amino phenyl acetic acid derivative which inhibits prostaglandin biosynthesis to produce analgesic, antipyretic and anti-inflammatory effect. The drug efficacy and safety in acute pain management has been proved by several studies like in renal colic, post and pre-operative pain management, migraines etc. It's also known to have an opioid-sparing effect. Mode of administration is one of the important factors to consider in a busy emergency room. Perception about the route of administration differs among patients. As believed,injectable have rapid onset, easier to titrate, and patients respond better to them as they consider them stronger than oral medication. Number of trials has compared oral and parenteral NSAIDs. Most found no benefit to the parenteral route. Considering the limitations of the previously done studies like small sample size, heterogeneity in the group of patients enrolled, improper blinding and comparing of two different drugs from the same class. Therefore, aim of the study is to conduct a Double blind randomized clinical trial to assess the clinical efficacy and pharmacokinetic parameters of oral diclofenac compared to intramuscular diclofenac in patients with acute limb injury.
In this two group double blind randomized clinical trial, the clinical efficacy and pharmacokinetic parameters among the two groups will be assessed. Eligible patients visiting to HGH-ED, age (above 18 years) with acute limb injury, having moderate to severe pain (defined as pain score of >=4 on Numerical rating scale) will be recruited. With the use of computer generated block randomization, subjects will be allocated to one of the two treatment groups in the ratio of 1:1. Each group will receive either (intramuscular diclofenac / oral placebo) or (oral diclofenac / intramuscular placebo). Among the 300 subjects enrolled for the study, further stratified randomization will be done in order to enroll 20 patients for pharmacokinetic study within the subjects.High-performance liquid chromatography, method will be used for the determination of drug concentration in human plasma, for detailed pharmacokinetics. The pain score will be assessed by using the validated pain scale i.e. Numerical rating scale (NRS). The participants, clinicians and investigators will be masked to treatment assigned and the results will be analyzed by the intention to treat analysis among the two group treatment.
Detailed description
This will be a prospective, double blinded, randomized clinical trial, and it will be conducted and reported according to the consolidated standards of reporting trials group 14.
Setting:
The study will be conducted at Hamad General Hospital Emergency Department (HGH-ED). Since it is the largest tertiary care medical center in the country, having a busy ED with monthly census exceeding 40,000 (approximately 500,000 annually). Patients with acute limb injury are frequently seen in ED.
Sample size calculation:
300 patients are required to have a 95% chance of detecting, as significant at the 5%level, a decrease in the primary outcome measure from 70% in the control group to 50% in the experimental group. As for the number of subjects to be enrolled in pharmacokinetic study is directly related to both power and cost of the trial (14)*, we aim a convenience sample of 20 subjects, 10 in each group.
Screening and Randomization:
All adult patients (age above 18-65 years) presenting with Acute limb injury will be assessed by the available physician initially. Patient's hospital identification number will be put into the study registry. The registry will assure all consecutive patients are screened. Once an eligible patient is identified the physicians will page the research assistant, who will be available in the emergency department from 6 am to 2 pm on week days. After meeting the inclusion criteria and the subject agrees to participate, written consent will be obtained. The enrolled participants will be randomly assigned in a 1:1 ratio, to one of the two groups- either intramuscular diclofenac or oral diclofenac, from the trial packet available in the stock.
A computer generated block randomization sequence will be generated and stored with sequential coding known to the clinical pharmacist only. Within the randomized sequence, another stratified randomized sequence will be generated for the 20 subjects to be enrolled for pharmacokinetic trial only during the morning shifts. In case of adverse reaction form will be filled and medical research center will be notified for such event.
Intervention:
Typical trial packet
- Syringe A: 3ml solution, diclofenac 75mg or placebo
- Tablet: 100mg diclofenac tablet or placebo A trial packet will contain one syringe labelled A (3ml) and one tablet labelled B (100mg) in an amber colored zip lock pouch. Each will be labelled with a sticker mentioning a unique code, date of preparation and instructions for administration.
Trial packs A B Combination 1 Intramuscular Diclofenac Oral Placebo Combination 2 Oral Diclofenac Intramuscular Placebo Trial packs will be prepared and kept in a locker ready to be used on a daily basis. The team preparing these packets will have no further part in patient treatment or data recording.
Dosage
- Intramuscular Diclofenac will be available in 75mg/3ml concentration for single dose intramuscular administration.
- Tablet Diclofenac will be available as 100mg tablet for single dose per oral administration.
The protocol dictates to administer syringe "A" (3ml) intramuscular, 100mg tablet labeled "B" to administer per oral.
Data and sample collection:
Patient enrolled for pharmacokinetic measurement, will have an intravenous line to obtain blood for routine sampling, a hep- lock will be attached to the line, for the withdrawal of repeated samples. Blood samples will be collected only in weekdays and morning shifts from 6am until 2 pm. 3 ml of blood will be withdrawn at time 0, 5, 10, 15, 20, 25, 30, 45 and 60 minutes. High- performance liquid chromatography method will be used to determine drug in human plasma as the method is potentially considered to be used for detailed pharmacokinetics, pharmacodynamics and bioequivalence studies of diclofenac in humans. Along with blood sampling patient pain score using a numerical rating scale (NRS) will be used to assess the pain, as for the rest of the patients. Pain scores will be recorded at 0, 5, 10, 15, 20, 25, 30, 45 and 60, minutes following administration of analgesia. Patients reported pain scores will be recorded contemporaneously and patient will not be reminded of the previous score. If patients pain does not reduce significantly at the end of 30 minutes after receiving the study drug, a rescue analgesia in the form of morphine will be given 3mg intravenously every 5 minutes until sedation side effects or pain drops to Numerical rating score = or <2.Patient will be discharged as per the advice of the available physician in ED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Diclofenac Sodiumdiclofenac sodium75 mg, intravenously, once |
| Group B | Active comparator | Drug: Diclofenac Sodiumdiclofenac sodium 100 mg, orally, once |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy volunteers
- Adult patients above 18-65 years of age.
- Patients with soft tissue injury/ cut wounds
- Pain score more than or equal to 4 on NRS.
- Patients weight more than or equal to 50kgs.
Key exclusion criteria (9 listed)
- Received any analgesic within last 12 hours, on the day of visit to ED.
- Patients with fractures
- Allergic to diclofenac.
- Cardio-vascular disease, renal impairment, stroke or any other co-morbidity / chronic illness.
- Pregnancy / Nursing
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 |
|---|---|---|
| Diclofenac SodiumGroup A-Intramuscular diclofenac sodium+oral placebo Group B-Oral diclofenac sodium+ intramuscular placebo | Drug | Group A, Group B |
Primary outcome
Difference in proportion of patients achieving 50% pain reduction
Time frame: 30 mins
The primary outcome is defined as the proportion of patients achieving pain reduction by 50% at 30 minutes following analgesia administration.
the mean difference in plasma concentration for two drugs
Time frame: 60 mins
Cmax - Peak plasma concentration and Time curve
3 secondary outcomes
proportion of patients achieving pain reduction of >=2 Numerical Rating Scale( which is a numeric scale where respondent selects a whole number from 0 to 10, where 0 means no pain and 10 means worst pain) from the initial score
Time frame: at 30 mins
Rescue analgesia
Time frame: after 30 mins
Adverse events
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Background: PubMed 19370609Derry P, Derry S, Moore RA, McQuay HJ. Single dose oral diclofenac for acute postoperative pain in adults. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004768. doi: 10.1002/14651858.CD004768.pub2.
- Background: PubMed 15915040Marret E, Kurdi O, Zufferey P, Bonnet F. Effects of nonsteroidal antiinflammatory drugs on patient-controlled analgesia morphine side effects: meta-analysis of randomized controlled trials. Anesthesiology. 2005 Jun;102(6):1249-60. doi: 10.1097/00000542-200506000-00027.
- Background: PubMed 26993881Pathan SA, Mitra B, Straney LD, Afzal MS, Anjum S, Shukla D, Morley K, Al Hilli SA, Al Rumaihi K, Thomas SH, Cameron PA. Delivering safe and effective analgesia for management of renal colic in the emergency department: a double-blind, multigroup, randomised controlled trial. Lancet. 2016 May 14;387(10032):1999-2007. doi: 10.1016/S0140-6736(16)00652-8. Epub 2016 Mar 16.
- Background: PubMed 22886837Gan TJ, Daniels SE, Singla N, Hamilton DA, Carr DB. A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study. Anesth Analg. 2012 Nov;115(5):1212-20. doi: 10.1213/ANE.0b013e3182691bf9. Epub 2012 Aug 10.
- Background: PubMed 7618770Turturro MA, Paris PM, Seaberg DC. Intramuscular ketorolac versus oral ibuprofen in acute musculoskeletal pain. Ann Emerg Med. 1995 Aug;26(2):117-20. doi: 10.1016/s0196-0644(95)70138-9.
- Background: PubMed 27513404Ucar R, Biyik M, Ucar E, Polat I, Cifci S, Ataseven H, Demir A. Rectal or intramuscular diclofenac reduces the incidence of pancreatitis afterendoscopic retrograde cholangiopancreatography. Turk J Med Sci. 2016 Jun 23;46(4):1059-63. doi: 10.3906/sag-1502-104.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac Sodium in people with Pain Management and Limb Injury, run by Hamad Medical Corporation at 1 site in Qatar.
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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in proportion of patients achieving 50% pain reduction (time frame: 30 mins). The study lists 2 primary outcomes in all. 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 NCT03472339, which also lists 6 linked publications.
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 22 Mar 2018.