Back PainPhase 1/2NCT04799041
Gonyautoxin 2/3 in the Treatment of Acute Back Pain: A Clinical Proof-of-concept Study
A Phase 1/2 study testing GTX 2/3 in people with Back Pain and Acute Pain, run by Algenis SpA at 1 site in Chile.
Trial summary
This was an interventional, double-blind, placebo controlled, randomized, single dose, proof-of-concept study. It was a single-center clinical trial. The purpose of the study was to explore the clinical efficacy and safety of a single local IM injection of gonyautoxin 2/3 (GTX 2/3) compared to placebo in decreasing… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Back Pain, Acute Pain
- What is being tested?
- GTX 2/3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 11 Oct 2019to 19 Mar 2020
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman patients between 18 and 75 years old.
- Acute back pain episode without radiculopathy asociated and no red flags.
- Back pain related pain bigger than 4 in VAS.
- Patients with no severe illnesses or conditions that would be inappropriate to enroll in this study or patients with no chronic pain.
- Signed informed consent.
Who cannot join
- Pregnant women or breastfeeding.
- Hyper acute back pain that requires emergency hospitalization.
- Chronic back pain or complicated (red flags).
- Patients that have received previous analgesic therapy of long half life, like corticoids, for current back pain or other pathology (inhalers are excluded).
- Associated neuromuscular diseases, inflammatory diseases in the spine (Musculoskeletal Disorders 2017, 18; 454: 2-12), inability to stand up, tumoral diseases, terminal disease.
- Ongoing local treatment with calcium antagonists or trinitroglycerin.
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- Treatment with anti-vitamins K or another anticoagulant.
- Patients with adverse psychosomatic, work or social factors.
- Known or suspected allergy to any component of the study drug.
- Current participation in another clinical study or 30 days prior to enrollment.
- Another condition that in the opinion of the PI prevents participation in the study (physical or mental) or that cannot attend controls or answer the patient's survey / diary.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gonyautoxin 2/3 in the Treatment of Acute Back Pain (Study No CLN 17-032): A Clinical Proof-of-concept Study
This was an interventional, double-blind, placebo controlled, randomized, single dose, proof-of-concept study. It was a single-center clinical trial.
The purpose of the study was to explore the clinical efficacy and safety of a single local IM injection of gonyautoxin 2/3 (GTX 2/3) compared to placebo in decreasing pain and improving lumbar functionality at short term follow-up in adult patients with acute low back pain, without radiculopathy.
Read the detailed description
This was an interventional, double-blind, placebo controlled, randomized, single dose, proof-of-concept study. It was a single-center clinical trial.
The primary objective was to determine the clinical efficacy of GTX 2/3 in the decrease of pain and in the functional improvement of adults patients with acute back pain with no associated radiculopathy. The secondary objective was to determine the safety of a local intramuscular injection of GTX 2/3 in adults patients with acute back pain.
Thirty subjects were studied in 2 groups, each consisting of 15 subjects. One group received the Investigational Medicinal Product (IMP) and the other group received placebo.
The eligible patients were adults, from both sex, aged between 18 and 70 years, with an episode of acute back pain without radiculopathy, with a pain intensity higher than 4 in the VAS scale, with no chronic pain and without any severe pathology.
Each subject participated in 1 treatment group only. All subjects received IV administration of 100 mg Ketoprofen before the IMP injection. All patients returned for a follow-up visit at day 4 after dose administration and at day 7 for discharge. Follow up telephone calls were done on day 1, 2 and 3 after the administration.
Each subject received only a single dose of GTX 2/3 or placebo during the study. Doses were administered as IM paravertebral injections, 1 mL per site. Total of 2 mL of GTX 2/3 or placebo. The IMP was supplied in glass vials containing 1.2 mL solution at a total GTX 2 and GTX 3 concentration of 40 mcg/mL (at a relative epimer ratio of 62% GTX 2:38% GTX 3). The total concentration of drug administrated was 80 mcg. Placebo was of identical appearance to the IMP.
Patients that participated in the study had the possibility of using rescue medication. As a first line medication was Ketoprofen (maximum of 200 mg per day) and as a second line analgesia was Tramadol®.
The primary efficacy endpoints were the mean change in pain intensity and lumbar function from baseline to day 4, as measured by VAS and RMDQ scores, respectively. Secondary outcomes were: 1) the mean change in pain intensity and lumbar function from baseline to day 7 as measured by VAS and RMDQ scores, respectively, 2) the frequency of use of rescue pain drugs during Days 1 to 3, and 3) the occurrence of adverse events during the 7 days of the study period.
- Conditions
- Back Pain, Acute Pain
- Being tested
- GTX 2/3, Placebo
- Keywords
- Low Back Pain, Acute Pain, Gonyautoxin, Paralytic Shellfish Poison, Muscle Relaxants
- Medical subject headings
- Back Pain, Acute Pain, Low Back Pain, Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTX 2/3Drug
Also called NAVX-010 (drug internal name), Gonyautoxin 2/3
There were 15 patients in this group. Each one received only one treatment.
PlaceboDrug
Also called Placebo of NAVX-010
There were 15 patients in this group. Each one received only one treatment.
| Study group | Role | What they receive |
|---|---|---|
| GTX 2/3 | Active comparator | Dose level administered of GTX 2/3 was 80 mcg. Dose was administered as IM paravertebral injections, 1 mL per site. Total of 2 mL of GTX 2/3 was injected. The IMP was supplied in glass vials containing 1.2 mL solution at a total GTX 2 and GTX 3 concentration of 40 mcg/mL (at a relative epimer ratio of 62% GTX 2:38% GTX 3). Receives: Drug: GTX 2/3 |
| Placebo | Placebo comparator | Placebo was of identical appearance to the IMP, and was administered as IM paravertebral injections, 1 mL per site. Total of 2 mL of placebo was injected. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of GTX 2/3 in the treatment of acute back pain after 4 days of administration.
Change of pain (0- to 10-point on a Visual Analog Scale (VAS), 0 meaning no pain and 10 the worst pain) and/or functional improvement (0- to 24-point on the Roland-Morris Disability Questionnaire (RMDQ). Each question is one point so scores can range from 0 (no disability) to 24 (severe disability)) in patients with acute back pain without radiculopathy from baseline to day 4 day after one local administration of GTX 2/3 or placebo.
Measured: 4 days after one local administration
Secondary outcomes (7)
Efficacy of GTX 2/3 in the treatment of acute back pain after 7 days of administration.
Change of pain (0- to 10-point on a Visual Analog Scale (VAS), 0 meaning no pain and 10 the worst pain) and/or functional improvement (0- to 24-point on the Roland-Morris Disability Questionnaire (RMDQ). Each question is one point so scores can range from 0 (no disability) to 24 (severe disability)) in patients with acute back pain without radiculopathy from baseline to day 7 day after one local administration of GTX 2/3 or placebo.
Measured: 7 days after one local administration
Pain evaluation after 2 hours of GTX 2/3 administration (Discharge of the hospital)
Pain evaluation using a Visual Analog Scale (0 no pain and 10 the worst pain) after 2 hours of GTX 2/3 or placebo administration, before the discharge of the patient from the hospital.
Measured: 2 hours after one local administration
Pain evaluation on day 1 after GTX 2/3 administration.
Pain evaluation using a Visual Analog Scale (0 no pain and 10 the worst pain) after day 1 of GTX 2/3 or placebo administration.
Measured: 1 day after one local administration
Pain evaluation on day 2 after GTX 2/3 administration.
Pain evaluation using a Visual Analog Scale (0 no pain and 10 the worst pain) after day 2 of GTX 2/3 or placebo administration.
Measured: 2 day after one local administration
Pain evaluation on day 3 after GTX 2/3 administration.
Pain evaluation using a Visual Analog Scale (0 no pain and 10 the worst pain) after day 3 of GTX 2/3 or placebo administration.
Measured: 3 day after one local administration
Use of rescue medication
Use of rescue medication on day 1, 2 and 3 after GTX 2/3 or placebo administration.
Measured: 3 days
Safety of GTX 2/3 by questioning the patients.
Search of side effects through questioning the patients during all the observation period (7 days). The adverse events questioned included: pain at site injection, perioral paresthesia, limbs paresthesia, headache, nausea, itching at site injection, allergy and ataxia. Indication to notify any event after this period of time.
Measured: Through the 7 days of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start11 Oct 2019
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a double-blind, placebo-controlled, randomized study in patients with acute back pain. This was a proof of concept study to determine efficacy and safety in two groups: active and placebo. Each patient participated in only one group. This was a single-center clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algenis SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Bravo, MD, Principal investigator, Hospital San José
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799041
- Sponsor's protocol ID
- CLN 17-032 (Chilean Number)
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 16 Mar 2021
- 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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gonyautoxin 2/3 in the Treatment of Acute Back Pain (Study No CLN 17-032): A Clinical Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT04799041
- Acronym / sponsor ID
- CLN 17-032 (Chilean Number)
- Conditions
- Back Pain, Acute Pain
- Keywords
- Low Back Pain, Acute Pain, Gonyautoxin, Paralytic Shellfish Poison, Muscle Relaxants
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Algenis SpAIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 16 Mar 2021 (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.
This was an interventional, double-blind, placebo controlled, randomized, single dose, proof-of-concept study. It was a single-center clinical trial.
The purpose of the study was to explore the clinical efficacy and safety of a single local IM injection of gonyautoxin 2/3 (GTX 2/3) compared to placebo in decreasing pain and improving lumbar functionality at short term follow-up in adult patients with acute low back pain, without radiculopathy.
Detailed description
This was an interventional, double-blind, placebo controlled, randomized, single dose, proof-of-concept study. It was a single-center clinical trial.
The primary objective was to determine the clinical efficacy of GTX 2/3 in the decrease of pain and in the functional improvement of adults patients with acute back pain with no associated radiculopathy. The secondary objective was to determine the safety of a local intramuscular injection of GTX 2/3 in adults patients with acute back pain.
Thirty subjects were studied in 2 groups, each consisting of 15 subjects. One group received the Investigational Medicinal Product (IMP) and the other group received placebo.
The eligible patients were adults, from both sex, aged between 18 and 70 years, with an episode of acute back pain without radiculopathy, with a pain intensity higher than 4 in the VAS scale, with no chronic pain and without any severe pathology.
Each subject participated in 1 treatment group only. All subjects received IV administration of 100 mg Ketoprofen before the IMP injection. All patients returned for a follow-up visit at day 4 after dose administration and at day 7 for discharge. Follow up telephone calls were done on day 1, 2 and 3 after the administration.
Each subject received only a single dose of GTX 2/3 or placebo during the study. Doses were administered as IM paravertebral injections, 1 mL per site. Total of 2 mL of GTX 2/3 or placebo. The IMP was supplied in glass vials containing 1.2 mL solution at a total GTX 2 and GTX 3 concentration of 40 mcg/mL (at a relative epimer ratio of 62% GTX 2:38% GTX 3). The total concentration of drug administrated was 80 mcg. Placebo was of identical appearance to the IMP.
Patients that participated in the study had the possibility of using rescue medication. As a first line medication was Ketoprofen (maximum of 200 mg per day) and as a second line analgesia was Tramadol®.
The primary efficacy endpoints were the mean change in pain intensity and lumbar function from baseline to day 4, as measured by VAS and RMDQ scores, respectively. Secondary outcomes were: 1) the mean change in pain intensity and lumbar function from baseline to day 7 as measured by VAS and RMDQ scores, respectively, 2) the frequency of use of rescue pain drugs during Days 1 to 3, and 3) the occurrence of adverse events during the 7 days of the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This was a double-blind, placebo-controlled, randomized study in patients with acute back pain. This was a proof of concept study to determine efficacy and safety in two groups: active and placebo. Each patient participated in only one group. This was a single-center clinical trial.
| Arm | Type | Receives |
|---|---|---|
| GTX 2/3 | Active comparator | Drug: GTX 2/3Dose level administered of GTX 2/3 was 80 mcg. Dose was administered as IM paravertebral injections, 1 mL per site. Total of 2 mL of GTX 2/3 was injected. The IMP was supplied in glass vials containing 1.2 mL solution at a total GTX 2 and GTX 3 concentration of 40 mcg/mL (at a relative epimer ratio of 62% GTX 2:38% GTX 3). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo was of identical appearance to the IMP, and was administered as IM paravertebral injections, 1 mL per site. Total of 2 mL of placebo was injected. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Man or woman patients between 18 and 75 years old.
- Acute back pain episode without radiculopathy asociated and no red flags.
- Back pain related pain bigger than 4 in VAS.
- Patients with no severe illnesses or conditions that would be inappropriate to enroll in this study or patients with no chronic pain.
- Signed informed consent.
Key exclusion criteria (11 listed)
- Pregnant women or breastfeeding.
- Hyper acute back pain that requires emergency hospitalization.
- Chronic back pain or complicated (red flags).
- Patients that have received previous analgesic therapy of long half life, like corticoids, for current back pain or other pathology (inhalers are excluded).
- Associated neuromuscular diseases, inflammatory diseases in the spine (Musculoskeletal Disorders 2017, 18; 454: 2-12), inability to stand up, tumoral diseases, terminal disease.
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 |
|---|---|---|
| GTX 2/3Also: NAVX-010 (drug internal name), Gonyautoxin 2/3There were 15 patients in this group. Each one received only one treatment. | Drug | GTX 2/3 |
| PlaceboAlso: Placebo of NAVX-010There were 15 patients in this group. Each one received only one treatment. | Drug | Placebo |
Primary outcome
Efficacy of GTX 2/3 in the treatment of acute back pain after 4 days of administration.
Time frame: 4 days after one local administration
Change of pain (0- to 10-point on a Visual Analog Scale (VAS), 0 meaning no pain and 10 the worst pain) and/or functional improvement (0- to 24-point on the Roland-Morris Disability Questionnaire (RMDQ). Each question is one point so scores can range from 0 (no disability) to 24 (severe disability)) in patients with acute back pain without radiculopathy from baseline to day 4 day after one local administration of GTX 2/3 or placebo.
7 secondary outcomes
Efficacy of GTX 2/3 in the treatment of acute back pain after 7 days of administration.
Time frame: 7 days after one local administration
Pain evaluation after 2 hours of GTX 2/3 administration (Discharge of the hospital)
Time frame: 2 hours after one local administration
Pain evaluation on day 1 after GTX 2/3 administration.
Time frame: 1 day after one local administration
Pain evaluation on day 2 after GTX 2/3 administration.
Time frame: 2 day after one local administration
Pain evaluation on day 3 after GTX 2/3 administration.
Time frame: 3 day after one local administration
Use of rescue medication
Time frame: 3 days
Safety of GTX 2/3 by questioning the patients.
Time frame: Through the 7 days of the study
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 16 Mar 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.
Francisco Bravo, MD principal investigator
Hospital San José
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GTX 2/3 in people with Back Pain and Acute Pain, run by Algenis SpA at 1 site in Chile.
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 5 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 16 Mar 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 Chile. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Efficacy of GTX 2/3 in the treatment of acute back pain after 4 days of administration. (time frame: 4 days after one local administration). 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 16 Mar 2021.