Opioid Induced Gait Variability

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03121547
• Date of registration: 10/04/2017
• Prospective Registration: No
• Primary sponsor: Frederiksberg University Hospital
• Public title: Opioid Induced Gait Variability
• Scientific title: Opioid Induced Gait Variability
• Date of first enrolment: May 19, 2015
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03121547
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Denmark

Contacts

• Name: Henning Bliddal, DMSc
• Affiliation: The Parker Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

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

- 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

Exclusion Criteria:

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

- 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



Age minimum: 50 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Opioid Induced Motor Disturbances

Intervention(s)

Drug: Tramadol Hydrochloride 100 mg Extended Release Oral Tablet

Drug: Tapentadol 50 mg Oral Tablet

Drug: Placebo Oral Tablet

Primary Outcome(s)

Changes in Gait variability [Time Frame: every hour from pre-tablet administration (hour 0) to hour 6]

Secondary Outcome(s)

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]

Secondary ID(s)

131

Source(s) of Monetary Support

Please refer to primary and secondary sponsors