Sciatica AcutePhase 3EDCLASNCT05626140
COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA
A Phase 3 study testing Lacosamide 50 MG Oral Tablet [Vimpat], Codeine Phosphate and Diclofenac Sodium in people with Sciatica Acute and Sciatica, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare different combinations of diclofenac with diclofenac monotherapy in acute sciatica. The main questions it aims to answer are: Does the combination of diclofenac plus codeine better than diclofenac monotherapy for treating severe pain of sciatica Does the combination of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sciatica Acute, Sciatica
- What is being tested?
- Lacosamide 50 MG Oral Tablet [Vimpat], Codeine Phosphate and Diclofenac Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Sep 2021to 31 Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with acute sciatica with or without lower back pain
- 18-70 years of age reporting acute pain due to sciatica
Who cannot join
- Pregnant or breastfeeding mothers.
- History of asthma or allergy to anti-inflammatory drugs.
- Mentally handicapped or terminally ill patients.
- Age less than 18 years or above 70 years
- Patients with herniated, sequestrated, or prolapsed discs waiting for surgery.
- Patient having an active ulcer (gastric or duodenal) or bleeding from the stomach or bowel.
- Patients already taking an anti-depressant medication, a medication for neuropathic pain, an anticonvulsant, or a sedative and unable to cease the medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF EFFICACY OF DICLOFENAC VERSUS DICLOFENAC PLUS CODEINE AND DICLOFENAC PLUS LACOSAMIDE IN ACUTE SCIATICA
The goal of this clinical trial is to compare different combinations of diclofenac with diclofenac monotherapy in acute sciatica. The main questions it aims to answer are:
- Does the combination of diclofenac plus codeine better than diclofenac monotherapy for treating severe pain of sciatica
- Does the combination of diclofenac plus lacosamide better than diclofenac monotherapy for treating severe pain of sciatica
Read more
Participants will be asked to mark their pain intensity on a visual analog scale and fill oswestry disabilit index questionnaire,treatments they'll be given includes either
- Diclofenac monotherapy
- Diclofenac plus codeine
- Diclofenac plus lacosamide
Researchers will compare the above three groups to see if severity of pain and disability lowered after medication
Read the detailed description
Musculoskeletal conditions are the most common cause of intense long-term pain, physical disability and early deaths. They affect hundreds of millions of people of all ages irrespective of social strata globally. Lumbar radicular pain (LRP), commonly referred to as "Sciatica" is a relatively common musculoskeletal disorder.
Objective of the study is to evaluate the efficacy of different drug combinations with diclofenac for the treatment of acute sciatica. The design of the study is Single-center, clinical trial with three arms. (Single Blinding). One hundred and twenty patients were enrolled in this study between September 2021 and July 2022 at the Pharmacology department of Islamic International Medical College (IIMC) Rawalpindi in collaboration with the Neurosurgery Department, of Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU) Pakistan Institute of Medical Sciences (PIMS) Islamabad. Informed verbal and written consent was taken from all patients. 40 patients were in the diclofenac (50 mg) plus placebo group, 40 in the codeine (30 mg) plus diclofenac (50 mg) group and 40 in lacosamide (50 mg) plus diclofenac (50 mg) group. Patients were followed up at day 5, 10 and 15 to assess change in pain intensity and functional disability. The use of rescue analgesia was also assessed at the final day of outcome
- Conditions
- Sciatica Acute, Sciatica
- Being tested
- Lacosamide 50 MG Oral Tablet [Vimpat], Codeine Phosphate, Diclofenac Sodium
- Keywords
- Acute Sciatica, Codeine, Diclofenac, Efficacy, Lacosamide
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacosamide 50 MG Oral Tablet [Vimpat]Drug
Also called Lacolap 50 mg, Vimpat 50 mg, Lalap 50 mg
Oral tablet lacosamide is a 3rd generation anti convulsant drug. it is given in a dose of 50 mg 12 hourly for 15 days. It has a longer half life than the other two drugs in comparison and fewer drug interactions as it doesnot interact with the hepatic cytochrome enzymes.hence it is seen to have better pharmacokinetics and pharmacodynamics than the other drugs in study
Codeine PhosphateDrug
Oral Codeine Phophate is an opioid with centrally acting pain alleviating mechanisms, shorter half life and metabolized to morphine in he body which is its active metabolite
Diclofenac SodiumDrug
Also called Artifen 50 mg, Dicloran 50 mg
Diclofenac sodium is a Cox 2 inhibitor non steroidal anti inflammatory drug with a half life of only 1.2 hrs but a longer action of duration due to its property to get distributed to synovial fluids. metabolized to hydroxy diclofenac and excreted via urine and bile both.
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac plus placebo | Placebo comparator | Oral tablet diclofeanc sodium 50 mg was given with tab folic acid 5 mg as placebo ,12 hourly for 15 days Receives: Drug: Diclofenac Sodium |
| Diclofenac plus codeine | Active comparator | Oral tablet diclofeanc sodium 50 mg was given with tab codeinephosphate 30 mg ,12 hourly for 15 days Receives: Drug: Codeine Phosphate; Drug: Diclofenac Sodium |
| Diclofenac plus lacosamide | Experimental | Oral tablet diclofeanc sodium 50 mg was given with tab lacosamide 50 mg as placebo ,12 hourly for 15 days Receives: Drug: Lacosamide 50 MG Oral Tablet [Vimpat]; Drug: Diclofenac Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Severity of leg pain or lower back pain associated with acute sciatica to be assessed using the visual analog scale VAS to determine if the mean pain scores decreased during the course of the medication. VAS is a commonly used pain score in interventinal studies and evaluating pain intensity related with musculoskeletal disorders or post opertive types of pain. For this , the patient is asked to mark a line anywhere on a 10 cm line with 0 taken on the left edge. The mark drawn on the line corresponds to the intensity pf pain experienced by the patient at the time of the pain assessment
Measured: Patients were asked to mark a line and record their pain scores at baseline and day 5, day 10 and day 15
Secondary outcomes (1)
Functional Disbability
The ODI is an index derived from the Oswestry Low Back Pain Questionnaire. The self-administered questionnaire consists of ten topics related to intensity of pain, lifting, ability of self-care, potential to walk, capacity to sit, sexual function, strength to stand, social life, quality of sleep, and capability to travel. Each category (topic) is then followed by 6 statements relating different potential scenarios in the patient's life concerning to the topic. Patients are inquired to specify the statement that most strictly is similar to their situation. Statements are linked with scores from 0 to 5, where 0 represents the lowest disability and 5 equivalent to extreme disability. The sum of the ten scores is stated as a percentage of the maximum score (50) ranging from 0% = no disability to 100% = maximum disability
Measured: ODI was measured at baseline and days 5,10, and 15 and patients were asked to fill the questionnaire on the respective days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start28 Sep 2021
- Primary completion31 May 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sciatica AcuteStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Collaborators
- Riphah International University
- Responsible party
- Principal investigator, Dr. Mehreen Mirza, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626140
- Sponsor's protocol ID
- PIMS-05-002
- Acronym
- EDCLAS
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF EFFICACY OF DICLOFENAC VERSUS DICLOFENAC PLUS CODEINE AND DICLOFENAC PLUS LACOSAMIDE IN ACUTE SCIATICA
- ClinicalTrials.gov ID
- NCT05626140
- Acronym / sponsor ID
- EDCLAS / PIMS-05-002
- Conditions
- Sciatica Acute, Sciatica
- Keywords
- Acute Sciatica, Codeine, Diclofenac, Efficacy, Lacosamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Collaborators
- Riphah International University
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 23 Nov 2022 (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.
The goal of this clinical trial is to compare different combinations of diclofenac with diclofenac monotherapy in acute sciatica. The main questions it aims to answer are:
- Does the combination of diclofenac plus codeine better than diclofenac monotherapy for treating severe pain of sciatica
- Does the combination of diclofenac plus lacosamide better than diclofenac monotherapy for treating severe pain of sciatica
Participants will be asked to mark their pain intensity on a visual analog scale and fill oswestry disabilit index questionnaire,treatments they'll be given includes either
- Diclofenac monotherapy
- Diclofenac plus codeine
- Diclofenac plus lacosamide
Researchers will compare the above three groups to see if severity of pain and disability lowered after medication
Detailed description
Musculoskeletal conditions are the most common cause of intense long-term pain, physical disability and early deaths. They affect hundreds of millions of people of all ages irrespective of social strata globally. Lumbar radicular pain (LRP), commonly referred to as "Sciatica" is a relatively common musculoskeletal disorder.
Objective of the study is to evaluate the efficacy of different drug combinations with diclofenac for the treatment of acute sciatica. The design of the study is Single-center, clinical trial with three arms. (Single Blinding). One hundred and twenty patients were enrolled in this study between September 2021 and July 2022 at the Pharmacology department of Islamic International Medical College (IIMC) Rawalpindi in collaboration with the Neurosurgery Department, of Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU) Pakistan Institute of Medical Sciences (PIMS) Islamabad. Informed verbal and written consent was taken from all patients. 40 patients were in the diclofenac (50 mg) plus placebo group, 40 in the codeine (30 mg) plus diclofenac (50 mg) group and 40 in lacosamide (50 mg) plus diclofenac (50 mg) group. Patients were followed up at day 5, 10 and 15 to assess change in pain intensity and functional disability. The use of rescue analgesia was also assessed at the final day of outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diclofenac plus placebo | Placebo comparator | Drug: Diclofenac SodiumOral tablet diclofeanc sodium 50 mg was given with tab folic acid 5 mg as placebo ,12 hourly for 15 days |
| Diclofenac plus codeine | Active comparator | Drug: Codeine Phosphate, Drug: Diclofenac SodiumOral tablet diclofeanc sodium 50 mg was given with tab codeinephosphate 30 mg ,12 hourly for 15 days |
| Diclofenac plus lacosamide | Experimental | Drug: Lacosamide 50 MG Oral Tablet [Vimpat], Drug: Diclofenac SodiumOral tablet diclofeanc sodium 50 mg was given with tab lacosamide 50 mg as placebo ,12 hourly for 15 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with acute sciatica with or without lower back pain
- 18-70 years of age reporting acute pain due to sciatica
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding mothers.
- History of asthma or allergy to anti-inflammatory drugs.
- Mentally handicapped or terminally ill patients.
- Age less than 18 years or above 70 years
- Patients with herniated, sequestrated, or prolapsed discs waiting for surgery.
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 |
|---|---|---|
| Lacosamide 50 MG Oral Tablet [Vimpat]Also: Lacolap 50 mg, Vimpat 50 mg, Lalap 50 mgOral tablet lacosamide is a 3rd generation anti convulsant drug. it is given in a dose of 50 mg 12 hourly for 15 days. It has a longer half life than the other two drugs in comparison and fewer drug interactions as it doesnot interact with the hepatic cytochrome enzymes.hence it is seen to have better pharmacokinetics and pharmacodynamics than the other drugs in study | Drug | Diclofenac plus lacosamide |
| Codeine PhosphateOral Codeine Phophate is an opioid with centrally acting pain alleviating mechanisms, shorter half life and metabolized to morphine in he body which is its active metabolite | Drug | Diclofenac plus codeine |
| Diclofenac SodiumAlso: Artifen 50 mg, Dicloran 50 mgDiclofenac sodium is a Cox 2 inhibitor non steroidal anti inflammatory drug with a half life of only 1.2 hrs but a longer action of duration due to its property to get distributed to synovial fluids. metabolized to hydroxy diclofenac and excreted via urine and bile both. | Drug | Diclofenac plus codeine, Diclofenac plus lacosamide, Diclofenac plus placebo |
Primary outcome
Pain Intensity
Time frame: Patients were asked to mark a line and record their pain scores at baseline and day 5, day 10 and day 15
Severity of leg pain or lower back pain associated with acute sciatica to be assessed using the visual analog scale VAS to determine if the mean pain scores decreased during the course of the medication. VAS is a commonly used pain score in interventinal studies and evaluating pain intensity related with musculoskeletal disorders or post opertive types of pain. For this , the patient is asked to mark a line anywhere on a 10 cm line with 0 taken on the left edge. The mark drawn on the line corresponds to the intensity pf pain experienced by the patient at the time of the pain assessment
1 secondary outcome
Functional Disbability
Time frame: ODI was measured at baseline and days 5,10, and 15 and patients were asked to fill the questionnaire on the respective days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lacosamide 50 MG Oral Tablet [Vimpat], Codeine Phosphate and Diclofenac Sodium in people with Sciatica Acute and Sciatica, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 2 inclusion and 7 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 23 Nov 2022. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Patients were asked to mark a line and record their pain scores at baseline and day 5, day 10 and day 15). 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 23 Nov 2022.