GonarthrosisPhase 4NCT02638831
Ketorol Gel in Gonarthrosis and Low Back Pain
A Phase 4 study testing Ketorolac Tromethamine and Ketoprofen in people with Gonarthrosis and Low Back Pain, run by Dr. Reddy's Laboratories Limited.
Trial summary
Comparative clinical study of Ketorolac tromethamineand Ketoprofen gel in patients with Gonarthrosis and Low back pain. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Gonarthrosis, Low Back Pain
- What is being tested?
- Ketorolac Tromethamine and Ketoprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Nov 2013
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 1. Feedback on Informed Consent Form signed by the patient for participation in the Study.
- 2. Continuation of participation in the study is in conflict with the patient's interests.
- 3. Occurrence of a serious adverse event in the patient, the relation of which to the administration of the drug under study is classified definite, probable or possible.
- 4. Patient needs additional treatment which may affect the parameters of efficacy under study.
- 5. Violations of the protocol, which in the opinion of the investigator or sponsor of the study, are significant for evaluation of results of the clinical trial.
- 6. Discontinuation of the study by the sponsor. 7. Discontinuation of the study by the investigator. 8. Discontinuation of the study by the regulatory bodies.
About this study
Official title: Open Label Randomized Study for Evaluating Efficacy and Safety of Ketorolac Tromethamine and Ketoprofen in Gel in Patients With Gonarthrosis and Low Back Pain
Comparative clinical study of Ketorolac tromethamineand Ketoprofen gel in patients with Gonarthrosis and Low back pain.
Read the detailed description
This is a Comparative evaluation of therapeutic efficacy and safety of use of drug Ketorolac tromethamine gel and drug Ketoprofen gel , as an agent of local symptomatic therapy in patients with diseases of musculoskeletal system with associated pain syndrome in outpatient conditions.
The study includes patients with moderate pain syndrome in gonarthrosis and lower back pain (LBP).
The sample size of 240 was calculated for the main efficacy variable - mean pain intensity according to the visual analogue scale (VAS) in 10 days of therapy.
Patients who subjected to inclusion into the study and had signed informed consent will be distributed into the study groups depending on established diagnosis: Gonarthrosis group and LBP group.
- Conditions
- Gonarthrosis, Low Back Pain
- Being tested
- Ketorolac Tromethamine, Ketoprofen
- Keywords
- Pain, Gonarthrosis, Low Back Pain, Ketorolac Tromethamine, Ketoprofen
- Medical subject headings
- Osteoarthritis, Knee, Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
Ketorolac tromethamine gel 2% for external application. Column of gel about 3-5 cm is applied on the area of maximum pain three times a day for 10 days
KetoprofenDrug
Ketoprofen gel 2.5% for external application Column of gel (3-5 cm) is applied with a thin layer on the skin in the area of maximum pain 3 times a day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac Tromethamine | Experimental | Ketorolac 2% for external application. Column of gel about 3-5 cm is applied on the area of maximum pain three times a day for 10 days Receives: Drug: Ketorolac Tromethamine |
| Ketoprofen | Active comparator | Ketoprofen gel 2.5% for external application. Column of gel (3-5 cm) is applied with a thin layer on the skin in the area of maximum pain 3 times a day for 10 days Receives: Drug: Ketoprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain on visual analogue scale (VAS) from baseline
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonarthrosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nadezhda A Shostak, PhD, Principal investigator, 1 Russian National Research Medical Institute State Budgetary Institution of Higher Professional Education "N.I. Pirogov Russian National Research Medical Institute" of the Ministry of Health of Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638831
- Sponsor's protocol ID
- DRL_RUS/PMS/2012/KETG
- Status last verified
- Mar 2017
- First submitted
- 1 Dec 2015
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Randomized Study for Evaluating Efficacy and Safety of Ketorolac Tromethamine and Ketoprofen in Gel in Patients With Gonarthrosis and Low Back Pain
- ClinicalTrials.gov ID
- NCT02638831
- Acronym / sponsor ID
- DRL_RUS/PMS/2012/KETG
- Conditions
- Gonarthrosis, Low Back Pain
- Keywords
- Pain, Gonarthrosis, Low Back Pain, Ketorolac Tromethamine, Ketoprofen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Dec 2015 (estimated)
- 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.
Comparative clinical study of Ketorolac tromethamineand Ketoprofen gel in patients with Gonarthrosis and Low back pain.
Detailed description
This is a Comparative evaluation of therapeutic efficacy and safety of use of drug Ketorolac tromethamine gel and drug Ketoprofen gel , as an agent of local symptomatic therapy in patients with diseases of musculoskeletal system with associated pain syndrome in outpatient conditions.
The study includes patients with moderate pain syndrome in gonarthrosis and lower back pain (LBP).
The sample size of 240 was calculated for the main efficacy variable - mean pain intensity according to the visual analogue scale (VAS) in 10 days of therapy.
Patients who subjected to inclusion into the study and had signed informed consent will be distributed into the study groups depending on established diagnosis: Gonarthrosis group and LBP group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac Tromethamine | Experimental | Drug: Ketorolac TromethamineKetorolac 2% for external application. Column of gel about 3-5 cm is applied on the area of maximum pain three times a day for 10 days |
| Ketoprofen | Active comparator | Drug: KetoprofenKetoprofen gel 2.5% for external application. Column of gel (3-5 cm) is applied with a thin layer on the skin in the area of maximum pain 3 times a day for 10 days |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 1. Feedback on Informed Consent Form signed by the patient for participation in the Study.
- 2. Continuation of participation in the study is in conflict with the patient's interests.
- 3. Occurrence of a serious adverse event in the patient, the relation of which to the administration of the drug under study is classified definite, probable or possible.
- 4. Patient needs additional treatment which may affect the parameters of efficacy under study.
- 5. Violations of the protocol, which in the opinion of the investigator or sponsor of the study, are significant for evaluation of results of the clinical trial.
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 |
|---|---|---|
| Ketorolac TromethamineKetorolac tromethamine gel 2% for external application. Column of gel about 3-5 cm is applied on the area of maximum pain three times a day for 10 days | Drug | Ketorolac Tromethamine |
| KetoprofenKetoprofen gel 2.5% for external application Column of gel (3-5 cm) is applied with a thin layer on the skin in the area of maximum pain 3 times a day for 10 days | Drug | Ketoprofen |
Primary outcome
Change in pain on visual analogue scale (VAS) from baseline
Time frame: 10 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 13 Mar 2017.
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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.
Nadezhda A Shostak, PhD principal investigator
1 Russian National Research Medical Institute State Budgetary Institution of Higher Professional Education "N.I. Pirogov Russian National Research Medical Institute" of the Ministry of Health of Russia
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac Tromethamine and Ketoprofen in people with Gonarthrosis and Low Back Pain, run by Dr. Reddy's Laboratories Limited.
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 0 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in pain on visual analogue scale (VAS) from baseline (time frame: 10 days). 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 13 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.