Acute Muscle PainPhase 2NCT02887534
Evaluation of Efficacy and Safety of SPARC1401 in Acute Low Back Pain
A Phase 2 study testing SPARC1401-low dose, SPARC1401-mid dose and SPARC1401-high dose in people with Acute Muscle Pain, run by Sun Pharma Advanced Research Company Limited.
Trial summary
A phase 2 randomized clinical trial to evaluate efficacy and safety of SPARC1401 at three dose levels in patients with acute low back pain Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Muscle Pain
- What is being tested?
- SPARC1401-low dose, SPARC1401-mid dose and SPARC1401-high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Dec 2017
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gives informed and written consent and is able to comply with all study assessments scheduled in the protocol
- Males or females aged 18 to 80 years (inclusive).
- Female subjects should be surgically sterile (bilateral tubal ligation at least 6 months prior to randomization, bilateral oophorectomy or hysterectomy performed) or if they are of child-bearing potential, should be willing to practice an acceptable method of birth control from screening to completion of study.
- Subjects will be considered eligible for this trial based on medical evaluation, electrocardiogram and laboratory values at screening, and laboratory values outside normal range considered of no clinical significance by the investigator
Who cannot join
- History or presence of clinically significant or uncontrolled cardiovascular, respiratory, neurological, psychiatric, hepatic, renal, gastrointestinal, hematological, or sleep disorder
- History or clinical signs or symptoms suggestive of stenosing peptic ulcer, pyloroduodenal obstruction, or inflammatory bowel disease
- History of diagnosis of cancer within 5 years prior to screening
- History of narrow-angle glaucoma, symptomatic prostatic hypertrophy, or bladder-neck obstruction
About this study
Official title: A Randomized, Double-blind, Active and Placebo-controlled, Study of SPARC1401 in Subjects With Moderate to Severe Acute Low Back Pain
A phase 2 randomized clinical trial to evaluate efficacy and safety of SPARC1401 at three dose levels in patients with acute low back pain
- Conditions
- Acute Muscle Pain
- Being tested
- SPARC1401-low dose, SPARC1401-mid dose, SPARC1401-high dose, Reference1401 (Tizanidine), Placebo1401
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC1401-low doseDrug
Also called Test 1
SPARC1401- low dose
SPARC1401-mid doseDrug
Also called Test 2
SPARC1401- mid dose
SPARC1401-high doseDrug
Also called Test 3
SPARC1401-high dose
Reference1401 (Tizanidine)Drug
Also called Reference1401
Reference1401 (Tizanidine) three times a day
Placebo1401Drug
Also called Placebo intervention
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | three times medication; SPARC1401-low dose Receives: Drug: SPARC1401-low dose; Drug: Placebo1401 |
| Arm 2 | Experimental | three times medication; SPARC1401-mid dose Receives: Drug: SPARC1401-mid dose; Drug: Placebo1401 |
| Arm 3 | Experimental | three times medication; SPARC1401-high dose Receives: Drug: SPARC1401-high dose; Drug: Placebo1401 |
| Active comparator | Active comparator | Reference1401; To be administered 3 times a day Receives: Drug: Reference1401 (Tizanidine) |
| Arm 5 | Placebo comparator | Placebo1401 - 3 three times a day Receives: Drug: Placebo1401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very good, 4 - excellent
Measured: Day 4
Secondary outcomes (1)
Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very, 4 - excellent
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startNov 2016 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Muscle 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887534
- Sponsor's protocol ID
- CLR_14_01
- Status last verified
- May 2019
- First submitted
- 20 Jul 2016
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active and Placebo-controlled, Study of SPARC1401 in Subjects With Moderate to Severe Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT02887534
- Acronym / sponsor ID
- CLR_14_01
- Conditions
- Acute Muscle Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Sep 2016 (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.
A phase 2 randomized clinical trial to evaluate efficacy and safety of SPARC1401 at three dose levels in patients with acute low back pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SPARC1401-low dose, Drug: Placebo1401three times medication; SPARC1401-low dose |
| Arm 2 | Experimental | Drug: SPARC1401-mid dose, Drug: Placebo1401three times medication; SPARC1401-mid dose |
| Arm 3 | Experimental | Drug: SPARC1401-high dose, Drug: Placebo1401three times medication; SPARC1401-high dose |
| Active comparator | Active comparator | Drug: Reference1401 (Tizanidine)Reference1401; To be administered 3 times a day |
| Arm 5 | Placebo comparator | Drug: Placebo1401Placebo1401 - 3 three times a day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gives informed and written consent and is able to comply with all study assessments scheduled in the protocol
- Males or females aged 18 to 80 years (inclusive).
- Female subjects should be surgically sterile (bilateral tubal ligation at least 6 months prior to randomization, bilateral oophorectomy or hysterectomy performed) or if they are of child-bearing potential, should be willing to practice an acceptable method of birth control from screening to completion of study.
- Subjects will be considered eligible for this trial based on medical evaluation, electrocardiogram and laboratory values at screening, and laboratory values outside normal range considered of no clinical significance by the investigator
Key exclusion criteria (4 listed)
- History or presence of clinically significant or uncontrolled cardiovascular, respiratory, neurological, psychiatric, hepatic, renal, gastrointestinal, hematological, or sleep disorder
- History or clinical signs or symptoms suggestive of stenosing peptic ulcer, pyloroduodenal obstruction, or inflammatory bowel disease
- History of diagnosis of cancer within 5 years prior to screening
- History of narrow-angle glaucoma, symptomatic prostatic hypertrophy, or bladder-neck obstruction
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 |
|---|---|---|
| SPARC1401-low doseAlso: Test 1SPARC1401- low dose | Drug | Arm 1 |
| SPARC1401-mid doseAlso: Test 2SPARC1401- mid dose | Drug | Arm 2 |
| SPARC1401-high doseAlso: Test 3SPARC1401-high dose | Drug | Arm 3 |
| Reference1401 (Tizanidine)Also: Reference1401Reference1401 (Tizanidine) three times a day | Drug | Active comparator |
| Placebo1401Also: Placebo interventionPlacebo | Drug | Arm 1, Arm 2, Arm 3, Arm 5 |
Primary outcome
Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very good, 4 - excellent
Time frame: Day 4
1 secondary outcome
Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very, 4 - excellent
Time frame: Day 8
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 3 May 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPARC1401-low dose, SPARC1401-mid dose and SPARC1401-high dose in people with Acute Muscle Pain, run by Sun Pharma Advanced Research Company 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 4 inclusion and 4 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 3 May 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very good, 4 - excellent (time frame: Day 4). 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 3 May 2019.