Low Back PainPhase 3DelfosNCT03508167
Security and Efficacy of Dorilax® (Fixed Association of Paracetamol 350 mg, Carisoprodol 150 mg and Caffeine 50 mg) Plus Thermal Band Compared to Placebo Plus Thermal Band in the Treatment of Acute Low Back Pain.
A Phase 3 study testing Thermal Band and Dorilax® in people with Low Back Pain, run by Ache Laboratorios Farmaceuticos S.A..
Trial summary
National clinical trial, phase III, monocentric, randomized, double-blind, controlled, parallel, study of superiority, in which two hundred and thirty four (234) participants of both sexes, aged equal or more than 18 years and equal or less than 54 years, will be randomly allocated in one of two treatment groups. Read more about this study
- Who is it for?
- Ages 18 to 54 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Thermal Band and Dorilax®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Nov 2020
- 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 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants of both sexes aged ≥ (greater than or equal) to 18 years and ≤ (less than or equal) to 54 years;
- Ability to understand and consent their participation in this clinical study, expressed by signing the Informed Consent Form (ICF);
- Patient with acute low back pain who responds to the pain period less than or equal to 3 days;
- Low back pain in intensity Moderate to severe which corresponds to the severity score at least to 2 scores, evaluated by a 6 scores categoric scale;
- No traumatic low back pain (with no traumatic lesion for at least 7 days before randomization)
- Low back pain not caused or related to any clinically significant systemic disease, based on investigator evaluation.
Who cannot join
- Any finding of clinical observation (clinical / physical assessment) that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical study;
- Any laboratorial finding that the Investigator consider a risk to subject of the study;
- Any finding of a previous imaging examination that the investigator considers to be a risk for clinical study participation;
- Known hypersensitivity to the components of the medicines used during the study;
- Women in pregnancy or nursing period;
- Women who do not agree to use acceptable contraceptive methods (oral contraceptive, intravenous contraceptive, intrauterine device (IUD), hormonal implant, barrier methods, hormonal transdermal patch and tubal ligation); except for those surgically sterile (bilateral oophorectomy or hysterectomy), menopause for at least one year, and participants who report not engaging in sexual practices or non-reproductive practices;
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- Male participants who did not agree to use acceptable methods of contraception;
- Subjects that has participated in clinical trial protocols in the last twelve (12) months (National Board of Health- Resolution 251 of 07 August 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to it;
- Subjects who have a relationship of kinship to second degree or any bond with the sponsor or research center employees;
- Any serious medical illness, at the discretion of the investigator. For example, sciatica that extends below the knee [associated with numbness, tingling, and acute and irradiated pain]) or other neurological deficits (eg, altered straight leg elevation test, abolished or diminished patellar reflex, function of the intestine and / or bladder); Orthopedic surgery history;Fibromyalgia; Diabetes mellitus; peripheral vascular disease; Osteoporosis; Gastrointestinal ulcers; Bleeding or perforation of the gastrointestinal tract; kidney disease; pulmonary edema; Cardiomyopathy; Liver disease; intrinsic defects of coagulation; Hemorrhagic diseases;
- Any skin lesions (eg rash, bruising, swelling, irritation, laceration, excoriation, ulceration) in the lower back.
- Use of β-adrenergic blocking agents, antidepressant drugs or supplements that have effects on the central nervous system or that used short- or long-acting analgesic drugs within 24 to 48 hours before randomization, respectively.
- History of alcohol and / or illicit drug abuse, involvement in active litigation, or worker's compensation claim involving lumbar spine deficiency, back pain for more than 28 consecutive days, or heat hypersensitivity or NSAIDs.
- Subjects with febrile condition (axillary temperature greater or equal to 37.8ºC)
- Subjects who have recently had a bacterial infection (last 90 days) that affect the vertebral column, pelvic or abdominal region; as well as participants with a history of bacterial infection that affected the spine in a chronic way;
- Subjects with unexplained weight loss (more than 10 kg in the last three months);
- Subjects who are performing some type of oral, physical or topical treatment for low back pain (eg acupuncture, local heat and yoga) and / or initiation of physiotherapy program in the last 2 months before the start of therapy. study;
- Diabetic subjects, controlled or not.
About this study
Official title: National, Phase III, Monocentric, Randomized, Double-blind, Controlled, Parallel, to Evaluate the Security and Efficacy of Dorilax® (Fixed Association of Paracetamol 350 mg, Carisoprodol 150 mg and Caffeine 50 mg) Plus Thermal Band Compared to Placebo Plus Thermal Band in the Treatment of Acute Low Back Pain.
National clinical trial, phase III, monocentric, randomized, double-blind, controlled, parallel, study of superiority, in which two hundred and thirty four (234) participants of both sexes, aged equal or more than 18 years and equal or less than 54 years, will be randomly allocated in one of two treatment groups. The first group will use Dorilax® plus thermal band and the second group will use thermal band plus placebo. The results will show the efficacy and security of Dorilax® and compare the efficiency of Dorilax® and thermal band.
- Conditions
- Low Back Pain
- Being tested
- Thermal Band, Dorilax®, Placebo
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal BandDevice
Thermal Band used 8 hours per day
Dorilax®Drug
2 tablets, orally. In case of moderate pain, another 2 tablets could be administered, respecting the interval of 8 hours between the administrations.
Maximum dosage per day: 6 tablets.
PlaceboDrug
2 tablets, orally. In case of moderate pain, another 2 tablets could be administered, respecting the interval of 8 hours between the administrations.
Maximum dosage per day: 6 tablets.
| Study group | Role | What they receive |
|---|---|---|
| Thermal Band plus Dorilax® | Experimental | Not described Receives: Device: Thermal Band; Drug: Dorilax® |
| Thermal Band plus Placebo | Other | Not described Receives: Device: Thermal Band; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the efficacy and security of Dorilax® plus thermal banc and Placebo plus thermal band
The relief of the pain will be evaluated using a 6 points scale.
0 = no relief; 1 = little relief; 2 = less than half of relief; 3 = more than half of relief; 4 = a lot of relief; 5 = complete relief;
The first 2 hours will be evaluated at the center and the other 6 hours the subject will need to provide a diary completed hourly with the pain evaluation.
Measured: 8 hours
Secondary outcomes (1)
Evaluation of participant satisfaction with treatment
Satisfaction of the research participant with the treatment, evaluated in the final visit (VF) by means of the visual analog scale of 100 points (EVA of 100mm, being 0mm = totally unsatisfied and 100mm = totally satisfied).
Measured: 72 (+24) hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study startJan 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Why it stopped: Study design will be reformulated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508167
- Sponsor's protocol ID
- ACH-DRL-03(01/17)
- Acronym
- Delfos
- Status last verified
- Jul 2019
- First submitted
- 16 Apr 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Phase III, Monocentric, Randomized, Double-blind, Controlled, Parallel, to Evaluate the Security and Efficacy of Dorilax® (Fixed Association of Paracetamol 350 mg, Carisoprodol 150 mg and Caffeine 50 mg) Plus Thermal Band Compared to Placebo Plus Thermal Band in the Treatment of Acute Low Back Pain.
- ClinicalTrials.gov ID
- NCT03508167
- Acronym / sponsor ID
- Delfos / ACH-DRL-03(01/17)
- Conditions
- Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study design will be reformulated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 25 Apr 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.
National clinical trial, phase III, monocentric, randomized, double-blind, controlled, parallel, study of superiority, in which two hundred and thirty four (234) participants of both sexes, aged equal or more than 18 years and equal or less than 54 years, will be randomly allocated in one of two treatment groups. The first group will use Dorilax® plus thermal band and the second group will use thermal band plus placebo. The results will show the efficacy and security of Dorilax® and compare the efficiency of Dorilax® and thermal band.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermal Band plus Dorilax® | Experimental | Device: Thermal Band, Drug: Dorilax® |
| Thermal Band plus Placebo | Other | Device: Thermal Band, Drug: Placebo |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants of both sexes aged ≥ (greater than or equal) to 18 years and ≤ (less than or equal) to 54 years;
- Ability to understand and consent their participation in this clinical study, expressed by signing the Informed Consent Form (ICF);
- Patient with acute low back pain who responds to the pain period less than or equal to 3 days;
- Low back pain in intensity Moderate to severe which corresponds to the severity score at least to 2 scores, evaluated by a 6 scores categoric scale;
- No traumatic low back pain (with no traumatic lesion for at least 7 days before randomization)
Key exclusion criteria (18 listed)
- Any finding of clinical observation (clinical / physical assessment) that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical study;
- Any laboratorial finding that the Investigator consider a risk to subject of the study;
- Any finding of a previous imaging examination that the investigator considers to be a risk for clinical study participation;
- Known hypersensitivity to the components of the medicines used during the study;
- Women in pregnancy or nursing period;
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 |
|---|---|---|
| Thermal BandThermal Band used 8 hours per day | Device | Thermal Band plus Dorilax®, Thermal Band plus Placebo |
| Dorilax®2 tablets, orally. In case of moderate pain, another 2 tablets could be administered, respecting the interval of 8 hours between the administrations. Maximum dosage per day: 6 tablets. | Drug | Thermal Band plus Dorilax® |
| Placebo2 tablets, orally. In case of moderate pain, another 2 tablets could be administered, respecting the interval of 8 hours between the administrations. Maximum dosage per day: 6 tablets. | Drug | Thermal Band plus Placebo |
Primary outcome
Compare the efficacy and security of Dorilax® plus thermal banc and Placebo plus thermal band
Time frame: 8 hours
The relief of the pain will be evaluated using a 6 points scale. 0 = no relief; 1 = little relief; 2 = less than half of relief; 3 = more than half of relief; 4 = a lot of relief; 5 = complete relief; The first 2 hours will be evaluated at the center and the other 6 hours the subject will need to provide a diary completed hourly with the pain evaluation.
1 secondary outcome
Evaluation of participant satisfaction with treatment
Time frame: 72 (+24) hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thermal Band and Dorilax® in people with Low Back Pain, run by Ache Laboratorios Farmaceuticos S.A..
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 6 inclusion and 18 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: withdrawn, as of the sponsor's last update on 8 Jul 2019. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Compare the efficacy and security of Dorilax® plus thermal banc and Placebo plus thermal band (time frame: 8 hours). 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 8 Jul 2019.