Chronic Low Back PainPhase 2NCT03201393
Low-Dose Naltrexone and Acetaminophen Combination in the Treatment of Chronic Low Back Pain (ANODYNE-4)
A Phase 2 study testing Low-dose naltrexone and acetaminophen combination in people with Chronic Low Back Pain and Lumbar Radiculopathy, run by Allodynic Therapeutics, Inc at 1 site in United States.
Trial summary
Treatment of chronic low-back pain with low-dose naltrexone and acetaminophen combination: a small, randomized, double-Blind, and placebo-controlled clinical trial with an open-label extension for none-responders Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain, Lumbar Radiculopathy
- What is being tested?
- Low-dose naltrexone and acetaminophen combination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 26 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is a male or female 18 years of age or older.
- A clinical diagnosis of nonmalignant, chronic low back pain (CLBP). LBP, as defined by Quebec Task Force in class 1 - pain without radiation and class 2 - pain with proximal radiation above the knee. CLBP is defined as being present for at least several hours a day, at least half the days in the previous 6 months, and being the principal pain condition. (In accordance with the NIH 2013 Task Force on Research Standards for Chronic Low Back Pain).
- The 24-hour average pain intensity (API) mean score for the baseline period is ≥ 4 and ≤ 8, [measured on the 11-point (0-10) numeric rating scale (NRS)] with each individual score ≥ 3. In addition, the Oswestry Disability Index (ODI) score during the Randomization Visit is ≥ 30% and ≤ 60%.
- 5. The patient agrees to refrain from taking opiate medications from Visit 1 to 7 days after the last dose of the study drug.
- 6. The patient agrees to limit their rescue pain medications to acetaminophen 2000 mg per day for the duration of the study.
- 7. The patient is willing and able to discontinue use of non-pharmacological pain management modalities (e.g. TENS, physical therapy, chiropractic manipulations, biofeedback, and acupuncture) for the duration of the study.
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- 8. The patient has been taking a stable dose of a medication with pain prevention potential for at least 6 weeks prior to the screening visit and agrees to not start, stop, or change the dose of any medication with pain prevention potential during the study period. (E.g., tricyclic antidepressants, anticonvulsants, selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), herbal preparations (e.g. feverfew or St. John's wort)). Botulinum toxin injections and steroid injections to the spine must be discontinued six months prior to Visit 1.
- 9. The patient is able to complete study questionnaires, comply with the study requirements and restrictions, and willing to provide written informed consent and authorize HIPAA.
- 10. The patient agrees not to undergo any elective surgery, including spine surgery or injections to the spine (e.g. botulinum toxin, steroid, etc.) for the duration of the study.
- 11. The Female patient who is premenopausal or postmenopausal less than 1 year, or have not had surgical sterilization (i.e., tubal ligation, partial or complete hysterectomy) must have a negative serum pregnancy test, be non-lactating, and commit to using adequate and reliable contraception throughout the study (e.g., barrier with additional spermicidal, intra-uterine device, hormonal contraception). Male patients must be surgically sterile or commit to the use of 2 different methods of birth control during the study and for 28 days after the study.
Who cannot join
- The patient has any condition consistent with Quebec Task Force Classification 3-11.
- The patient has another painful condition that may require analgesic medications, occurring regularly or intermittently (e.g. menstrual pain, carpal tunnel syndrome, arthritis, tendinitis, etc.).
- The patient has concomitant migraine unless he/she treats migraine attacks only with ergotamine or triptans.
- 4. Regular use of the following medications for any reason: acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), antipsychotic drugs, monoamine oxidase inhibitors, muscle relaxants, blood thinning medications (e.g., warfarin or heparin), or cannabinoids. Low-dose aspirin for cardiovascular disease prophylaxis is permitted.
- 5. Diagnosis of any concurrent medical or psychiatric condition; this includes, chronic unstable debilitating diseases such as Parkinson's disease, multiple sclerosis, cancer, significant renal impairment, significant hepatic impairment, etc.
- 6. The patient has a history or diagnosis of moderate-to-severe hepatic or renal impairment (>2 × the upper limit of normal [ULN] for alanine transaminase or aspartate transaminase. ≥1.5 × ULN for Alkaline Phosphatase, bilirubin, BUN, or Creatinine). (Patients with elevated bilirubin level due to Gilbert's syndrome are allowed).
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- 7. The patient has a history of the previous 5 years of abuse of any drug, prescription, illicit, or alcohol.
- 8. The Female patient is pregnant or breastfeeding. The Male patient is not practicing 2 different methods of birth control with their partner during the study, and for 28 days after the investigational drug last dose or will not remain abstinent during the study, and for 28 days after the last dose.
- 9. The patient has known-hypersensitivity to components of the investigational drug.
- 10. Participation in another study with an investigational drug within 30 days before Visit 1 or during the study.
- 11. The patient is in the opinion of the investigator, unsuitable to participate in this study for any other reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Annette C. Toledano, M.D.
North Miami, Florida, 33181
About this study
Official title: A Single Site, Phase 2B, Randomized, Double-Blind, Study to Assess the Efficacy, Safety, and Tolerability of Low-Dose Naltrexone and Acetaminophen Combination vs. Placebo in the Treatment of Chronic Low Back Pain (ANODYNE-4)
Treatment of chronic low-back pain with low-dose naltrexone and acetaminophen combination: a small, randomized, double-Blind, and placebo-controlled clinical trial with an open-label extension for none-responders
- Conditions
- Chronic Low Back Pain, Lumbar Radiculopathy
- Being tested
- Low-dose naltrexone and acetaminophen combination, Placebo
- Keywords
- Back pain, Neuropathic Pain, Radiculopathy, Allodynia
- Medical subject headings
- Radiculopathy, Back Pain, Neuralgia, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose naltrexone and acetaminophen combinationDrug
Twice a day
PlaceboDrug
Twice a day
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | Experimental | Not described Receives: Drug: Low-dose naltrexone and acetaminophen combination |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in mean 7-day, 24-hour Worst Pain Intensity (WPI).
The mean weekly WPI score will be derived from assessments recorded by patients daily at bedtime. The WPI score is measured on the 11-point (0-10) Numeric Rating Scale (NRS), (0=no pain, 10=worst possible pain).
Measured: From baseline to the last 7 days of the 12-week double-blind treatment period.
Secondary outcomes (8)
The change from baseline in mean 7-day, 24-hour Average Pain Intensity (API).
The mean weekly API score will be derived from assessments recorded by patients daily at bedtime. The API score is measured on the 11-point (0-10) NRS.
Measured: From baseline to the last 7 days of the 12-week double-blind treatment period.
Proportion of patients with 50% or more reduction in 7-day, 24-hour Worst Pain Intensity (WPI).
The mean weekly WPI score will be derived from assessments recorded by patients daily at bedtime. The WPI score is measured on the 11-point (0-10) NRS.
Measured: From baseline to the last 7 days of the 12-week double-blind treatment period.
The change from baseline in mean 7-day, 24-hour Right Now Pain Intensity (NPI).
The mean weekly NPI score will be derived from assessments recorded by patients daily at bedtime. The NPI score is measured on the 11-point (0-10) NRS.
Measured: From baseline to the last 7 days of the 12-week double-blind treatment period.
The change from baseline in mean 7-day, 24-hour Pain-Related Interference (PRI) with day-to-day activities.
The mean weekly PRI score will be derived from assessments recorded by patients daily at bedtime. The PRI score is measured on the 11-point (0-10) NRS.
Measured: From baseline to the last 7 days of the 12-week double-blind treatment period.
The change from baseline in mean 7-day, 24-hour pain-related sleep interference (PRSI).
The mean weekly PRSI score will be derived from assessments recorded by patients daily at bedtime. The PRSI score is measured on the 11-point (0-10) NRS.
Measured: From baseline to the last 7 days of the 12-week double-blind treatment period.
Change from baseline in the mean number of rescue medications used.
Rescue medications use will be derived from daily recordings by patients.
Measured: From baseline to the last 7 days of the 12-week treatment period.
Change from baseline in the mean Oswestry Disability Index (ODI).
Patients will complete the ODI instrument during site visits (%).
Measured: From baseline to the last 7 days of the 12-week double-blind treatment period.
Change from baseline in the mean Pittsburgh Insomnia Rating Scale-20 (PIRS-20).
Patients will complete the PIRS-20 instrument during site visits (0-60).
Measured: From baseline to the last 7 days of a 12-week double-blind treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start15 Aug 2017
- Primary completion26 Jul 2018
- Study completion26 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allodynic Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annette Toledano, M.D., Principal investigator, Allodynic Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201393
- Sponsor's protocol ID
- ANODYNE-4
- Status last verified
- Apr 2018
- First submitted
- 16 Jun 2017
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Site, Phase 2B, Randomized, Double-Blind, Study to Assess the Efficacy, Safety, and Tolerability of Low-Dose Naltrexone and Acetaminophen Combination vs. Placebo in the Treatment of Chronic Low Back Pain (ANODYNE-4)
- ClinicalTrials.gov ID
- NCT03201393
- Acronym / sponsor ID
- ANODYNE-4
- Conditions
- Chronic Low Back Pain, Lumbar Radiculopathy
- Keywords
- Back pain, Neuropathic Pain, Radiculopathy, Allodynia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Allodynic Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 28 Jun 2017 (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.
Treatment of chronic low-back pain with low-dose naltrexone and acetaminophen combination: a small, randomized, double-Blind, and placebo-controlled clinical trial with an open-label extension for none-responders
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | Experimental | Drug: Low-dose naltrexone and acetaminophen combination |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient is a male or female 18 years of age or older.
- A clinical diagnosis of nonmalignant, chronic low back pain (CLBP). LBP, as defined by Quebec Task Force in class 1 - pain without radiation and class 2 - pain with proximal radiation above the knee. CLBP is defined as being present for at least several hours a day, at least half the days in the previous 6 months, and being the principal pain condition. (In accordance with the NIH 2013 Task Force on Research Standards for Chronic Low Back Pain).
- The 24-hour average pain intensity (API) mean score for the baseline period is ≥ 4 and ≤ 8, [measured on the 11-point (0-10) numeric rating scale (NRS)] with each individual score ≥ 3. In addition, the Oswestry Disability Index (ODI) score during the Randomization Visit is ≥ 30% and ≤ 60%.
- 5. The patient agrees to refrain from taking opiate medications from Visit 1 to 7 days after the last dose of the study drug.
- 6. The patient agrees to limit their rescue pain medications to acetaminophen 2000 mg per day for the duration of the study.
Key exclusion criteria (11 listed)
- The patient has any condition consistent with Quebec Task Force Classification 3-11.
- The patient has another painful condition that may require analgesic medications, occurring regularly or intermittently (e.g. menstrual pain, carpal tunnel syndrome, arthritis, tendinitis, etc.).
- The patient has concomitant migraine unless he/she treats migraine attacks only with ergotamine or triptans.
- 4. Regular use of the following medications for any reason: acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), antipsychotic drugs, monoamine oxidase inhibitors, muscle relaxants, blood thinning medications (e.g., warfarin or heparin), or cannabinoids. Low-dose aspirin for cardiovascular disease prophylaxis is permitted.
- 5. Diagnosis of any concurrent medical or psychiatric condition; this includes, chronic unstable debilitating diseases such as Parkinson's disease, multiple sclerosis, cancer, significant renal impairment, significant hepatic impairment, etc.
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 |
|---|---|---|
| Low-dose naltrexone and acetaminophen combinationTwice a day | Drug | Low-Dose Naltrexone and Acetaminophen Combination |
| PlaceboTwice a day | Drug | Placebo |
Primary outcome
The change from baseline in mean 7-day, 24-hour Worst Pain Intensity (WPI).
Time frame: From baseline to the last 7 days of the 12-week double-blind treatment period.
The mean weekly WPI score will be derived from assessments recorded by patients daily at bedtime. The WPI score is measured on the 11-point (0-10) Numeric Rating Scale (NRS), (0=no pain, 10=worst possible pain).
8 secondary outcomes
The change from baseline in mean 7-day, 24-hour Average Pain Intensity (API).
Time frame: From baseline to the last 7 days of the 12-week double-blind treatment period.
Proportion of patients with 50% or more reduction in 7-day, 24-hour Worst Pain Intensity (WPI).
Time frame: From baseline to the last 7 days of the 12-week double-blind treatment period.
The change from baseline in mean 7-day, 24-hour Right Now Pain Intensity (NPI).
Time frame: From baseline to the last 7 days of the 12-week double-blind treatment period.
The change from baseline in mean 7-day, 24-hour Pain-Related Interference (PRI) with day-to-day activities.
Time frame: From baseline to the last 7 days of the 12-week double-blind treatment period.
The change from baseline in mean 7-day, 24-hour pain-related sleep interference (PRSI).
Time frame: From baseline to the last 7 days of the 12-week double-blind treatment period.
Change from baseline in the mean number of rescue medications used.
Time frame: From baseline to the last 7 days of the 12-week treatment period.
Change from baseline in the mean Oswestry Disability Index (ODI).
Time frame: From baseline to the last 7 days of the 12-week double-blind treatment period.
Change from baseline in the mean Pittsburgh Insomnia Rating Scale-20 (PIRS-20).
Time frame: From baseline to the last 7 days of a 12-week double-blind treatment period.
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 14 Apr 2021.
- 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.
Annette Toledano, M.D. principal investigator
Allodynic Therapeutics, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose naltrexone and acetaminophen combination in people with Chronic Low Back Pain and Lumbar Radiculopathy, run by Allodynic Therapeutics, Inc at 1 site in United States.
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 10 inclusion and 11 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 14 Apr 2021. 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 United States. 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 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 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?
The change from baseline in mean 7-day, 24-hour Worst Pain Intensity (WPI). (time frame: From baseline to the last 7 days of the 12-week double-blind treatment period.). 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 14 Apr 2021.