Opioid Induced Motor DisturbancesPhase 1/2NCT03121547
Opioid Induced Gait Variability
A Phase 1/2 study testing Tapentadol 50 mg Oral Tablet and Tramadol Hydrochloride 100 mg Extended Release Oral Tablet in people with Opioid Induced Motor Disturbances, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
While the analgesic effects of opioids are well known, evidence suggest that there are differences in the adverse dizziness of the different opioid types, which may influence the gait function differently. However, this has not been investigated scientifically under controlled conditions. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Induced Motor Disturbances
- What is being tested?
- Tapentadol 50 mg Oral Tablet and Tramadol Hydrochloride 100 mg Extended Release Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 19 May 2015to 29 Jan 2016
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects:
- In general good health, in the opinion of the Investigator, based on medical history and physical examination.
- Ability to comprehend and a willingness to provide written informed consent
- Age between 50 and 75 years
- No opioid usage 3 months prior to the study
- No musculoskeletal pain requiring medical attention during the previous 3 months
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- Willing and able to complete study visits and procedures
- Willing to hold activity, exercise level, and concurrent treatments/therapies generally consistent during the study
- A body mass index (BMI) of ≤30
- Patients with knee osteoarthritis (OA)
- Diagnosis of knee OA
- Ability to comprehend and a willingness to provide written informed consent
- Age between 50 and 75 years
- No opioid usage 3 months prior to the study
- Knee pain of at least 40 mm on a 0-100 mm visual analog scale (without analgesics) representing the average pain intensity during the previous week
- Willing to discontinue all pain medications 24 hours before and during examination visits
- Willing and able to complete study visits and procedures
- Willing to hold activity, exercise level, and concurrent treatments/therapies generally consistent during the study
- In general good health, in the opinion of the Investigator, based on medical history and physical examination.
- A body mass index (BMI) of ≤30
Who cannot join
- The same exclusion criteria apply for both healthy subjects and patients with knee osteoarthritis:
- Clinical signs of gait ataxia assessed by clinical neurological examination
- Independent or unsteady walking (i.e. dependence on walking device or stumbling gait)
- Counter indications to either of the investigational products, including but not restricted to:
- Allergy towards one or more of the investigational products or their excipient(s).
- Significant respiratory depression
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- Current or serious asthma
- Hypercapnia
- Suspected or diagnosed paralytic ileus
- Acute intoxication by alcohol, hypnotica, centrally acting analgesics, psychopharmaca or other pharmaceuticals.
- Renal dysfunction
- Hepatic dysfunction
- Diseases of the biliary tract
- Acute pancreatitis
- Usage of monoamine oxidase inhibitors within the last 14 days
- Galactose intolerance
- Lactase deficiency
- Glucose/galactose malabsorption
- Epilepsy
- Previous usage of opioids without pain reliving effect.
- Patients who have a documented history of an allergic reaction or a clinically significant intolerance to opioids
- Malignant pain
- Excessive joint laxity in the lower extremities indicative of functional ligamentous deficiency.
- Dependency of walking aid (stick, cane, roller etc.).
- Positive Clock Drawing Test
- Abuse of alcohol, medicine and narcotics within past 5 years.
- History of symptoms of autoimmune disorders
- Diabetes
- Pregnancy or breast feeding
- History, diagnosis, or signs and symptoms of clinically significant neurological disease
- History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
While the analgesic effects of opioids are well known, evidence suggest that there are differences in the adverse dizziness of the different opioid types, which may influence the gait function differently. However, this has not been investigated scientifically under controlled conditions. Normal gait function is characterized by cyclic movements with a high degree of predictability. As such, the amount of kinematic variability can provide important information about a condition or an intervention that may affect the gait function . Three-dimensional gait analysis is a recognized method to assess changes in stride-to-stride variability associated with a medical condition or caused by an intervention. Thus, opioid induced changes in gait variability, and possible differences between opioid types, can be assessed objectively from differences in the variability of movements obtained from a three-dimensional gait analysis.
The purpose of this study is to investigate differences in gait variability induced by two different single-dose opioid formulations and an inert placebo in healthy volunteers and knee osteoarthritis patients.
Read the detailed description
The study is designed as an experimental single center, double-blind treatment, cross-over study with inert placebo, Tapentadol (Palexia Depot), and Tramadolhydrochlorid (Mandolgin Retard), with a minimum of 7days wash-out periods.
At day 1 (Visit 1), baseline measurements are carried out before tablet administration. Immediately after baseline measurements one tablet is administered, and hourly measurements are performed for 6 hours. Subsequently all participants enter a minimum 7 day washout period, after which they return to the facility to repeat the procedures at Visit 2 (day 8+) and Visit 3 (day 15+). The order of treatments will be randomized (1:1:1).
- Conditions
- Opioid Induced Motor Disturbances
- Being tested
- Tapentadol 50 mg Oral Tablet, Tramadol Hydrochloride 100 mg Extended Release Oral Tablet, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol 50 mg Oral TabletDrug
Also called Palexia Depot (50 mg)
1 tablet administered
Tramadol Hydrochloride 100 mg Extended Release Oral TabletDrug
Also called Mandolgin Retard (100 mg)
1 tablet administered
Placebo Oral TabletDrug
Also called Calcium tablet
calcium tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo oral tablet | Placebo comparator | One inert calcium tablet is administered after a set of baseline measurements are performed. Subsequently outcomes are assessed every hour for 6 hours, yielding a total of 7 hourly measurements. Receives: Drug: Placebo Oral Tablet |
| Tramadol Hydrochloride 100 mg Extended Release Oral Tablet | Experimental | One tablet containing 100 milligrams (mg) Mandolgin Retard, Sandoz is administered after a set of baseline measurements are performed. Subsequently outcomes are assessed every hour for 6 hours, yielding a total of 7 hourly measurements. Receives: Drug: Tramadol Hydrochloride 100 mg Extended Release Oral Tablet |
| Tapentadol 50 mg Oral Tablet | Experimental | One tablet containing 50 milligrams (mg) Palexia Depot, Grünenthal is administered after a set of baseline measurements are performed. Subsequently outcomes are assessed every hour for 6 hours, yielding a total of 7 hourly measurements. Receives: Drug: Tapentadol 50 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gait variability
Three dimensional gait analysis during 6 minutes of continuous treadmill walking.
Measured: every hour from pre-tablet administration (hour 0) to hour 6
Secondary outcomes (2)
Self reported dizziness
Current dizziness is assessed by means of a 100 mm visual analog scale
Measured: every hour from pre-tablet administration (hour 0) to hour 6
Self reported knee pain
Current knee pain is assessed by means of a 100 mm visual analog scale
Measured: every hour from pre-tablet administration (hour 0) to hour 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start19 May 2015
- Primary completion29 Jan 2016
- Study completion29 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Induced Motor DisturbancesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henning Bliddal, Frederiksberg University Hospital
- Investigators
- Henning Bliddal, DMSc, Principal investigator, The Parker Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121547
- Sponsor's protocol ID
- 131
- Status last verified
- Nov 2017
- First submitted
- 10 Apr 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Henriksen M, Alkjaer T, Raffalt PC, Jorgensen L, Bartholdy C, Hansen SH, Bliddal H. Opioid-Induced Reductions in Gait Variability in Healthy Volunteers and Individuals with Knee Osteoarthritis. Pain Med. 2019 Nov 1;20(11):2106-2114. doi: 10.1093/pm/pny286.
PubMed 30649458
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Induced Gait Variability
- ClinicalTrials.gov ID
- NCT03121547
- Acronym / sponsor ID
- 131
- Conditions
- Opioid Induced Motor Disturbances
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- 19 May 2015 (actual)
- Primary completion
- 29 Jan 2016 (actual)
- Study completion
- 29 Jan 2016 (actual)
- First posted
- 20 Apr 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.
While the analgesic effects of opioids are well known, evidence suggest that there are differences in the adverse dizziness of the different opioid types, which may influence the gait function differently. However, this has not been investigated scientifically under controlled conditions. Normal gait function is characterized by cyclic movements with a high degree of predictability. As such, the amount of kinematic variability can provide important information about a condition or an intervention that may affect the gait function . Three-dimensional gait analysis is a recognized method to assess changes in stride-to-stride variability associated with a medical condition or caused by an intervention. Thus, opioid induced changes in gait variability, and possible differences between opioid types, can be assessed objectively from differences in the variability of movements obtained from a three-dimensional gait analysis.
The purpose of this study is to investigate differences in gait variability induced by two different single-dose opioid formulations and an inert placebo in healthy volunteers and knee osteoarthritis patients.
Detailed description
The study is designed as an experimental single center, double-blind treatment, cross-over study with inert placebo, Tapentadol (Palexia Depot), and Tramadolhydrochlorid (Mandolgin Retard), with a minimum of 7days wash-out periods.
At day 1 (Visit 1), baseline measurements are carried out before tablet administration. Immediately after baseline measurements one tablet is administered, and hourly measurements are performed for 6 hours. Subsequently all participants enter a minimum 7 day washout period, after which they return to the facility to repeat the procedures at Visit 2 (day 8+) and Visit 3 (day 15+). The order of treatments will be randomized (1:1:1).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo oral tablet | Placebo comparator | Drug: Placebo Oral TabletOne inert calcium tablet is administered after a set of baseline measurements are performed. Subsequently outcomes are assessed every hour for 6 hours, yielding a total of 7 hourly measurements. |
| Tramadol Hydrochloride 100 mg Extended Release Oral Tablet | Experimental | Drug: Tramadol Hydrochloride 100 mg Extended Release Oral TabletOne tablet containing 100 milligrams (mg) Mandolgin Retard, Sandoz is administered after a set of baseline measurements are performed. Subsequently outcomes are assessed every hour for 6 hours, yielding a total of 7 hourly measurements. |
| Tapentadol 50 mg Oral Tablet | Experimental | Drug: Tapentadol 50 mg Oral TabletOne tablet containing 50 milligrams (mg) Palexia Depot, Grünenthal is administered after a set of baseline measurements are performed. Subsequently outcomes are assessed every hour for 6 hours, yielding a total of 7 hourly measurements. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- In general good health, in the opinion of the Investigator, based on medical history and physical examination.
- Ability to comprehend and a willingness to provide written informed consent
- Age between 50 and 75 years
- No opioid usage 3 months prior to the study
- No musculoskeletal pain requiring medical attention during the previous 3 months
Key exclusion criteria (31 listed)
- The same exclusion criteria apply for both healthy subjects and patients with knee osteoarthritis:
- Clinical signs of gait ataxia assessed by clinical neurological examination
- Independent or unsteady walking (i.e. dependence on walking device or stumbling gait)
- Counter indications to either of the investigational products, including but not restricted to:
- Previous usage of opioids without pain reliving effect.
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 |
|---|---|---|
| Tapentadol 50 mg Oral TabletAlso: Palexia Depot (50 mg)1 tablet administered | Drug | Tapentadol 50 mg Oral Tablet |
| Tramadol Hydrochloride 100 mg Extended Release Oral TabletAlso: Mandolgin Retard (100 mg)1 tablet administered | Drug | Tramadol Hydrochloride 100 mg Extended Release Oral Tablet |
| Placebo Oral TabletAlso: Calcium tabletcalcium tablet | Drug | Placebo oral tablet |
Primary outcome
Changes in Gait variability
Time frame: every hour from pre-tablet administration (hour 0) to hour 6
Three dimensional gait analysis during 6 minutes of continuous treadmill walking.
2 secondary outcomes
Self reported dizziness
Time frame: every hour from pre-tablet administration (hour 0) to hour 6
Self reported knee pain
Time frame: every hour from pre-tablet administration (hour 0) to hour 6
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 6 Nov 2017.
- Derived from this study: PubMed 30649458Henriksen M, Alkjaer T, Raffalt PC, Jorgensen L, Bartholdy C, Hansen SH, Bliddal H. Opioid-Induced Reductions in Gait Variability in Healthy Volunteers and Individuals with Knee Osteoarthritis. Pain Med. 2019 Nov 1;20(11):2106-2114. doi: 10.1093/pm/pny286.
- Individual participant dataSharing planned: Undecided
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.
Henning Bliddal, DMSc principal investigator
The Parker Institute
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 Tapentadol 50 mg Oral Tablet and Tramadol Hydrochloride 100 mg Extended Release Oral Tablet in people with Opioid Induced Motor Disturbances, run by Frederiksberg University Hospital at 1 site in Denmark.
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 20 inclusion and 31 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 6 Nov 2017. 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 Denmark. 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?
Changes in Gait variability (time frame: every hour from pre-tablet administration (hour 0) to hour 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03121547, which also lists 1 linked publication.
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 6 Nov 2017.