HealthyPhase 1NCT01947920
A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers
A Phase 1 study testing Tramadol HCl, 50 mg in people with Healthy, run by Janssen Scientific Affairs, LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability profile of tramadol hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported by currently available toxicology and clinical data (200 mg to 600 mg per day). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tramadol HCl, 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2013
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index between 18 and 30 kg/m², inclusive
- body weight not less than 50 kg
- have a normal electroencephalogram under basic and stimulated conditions
- have a 12-lead ECG that is consistent with normal cardiac conduction and function
- have not used any tobacco products (eg, cigarettes, cigars, chewing tobacco, gum, or patch) for at least 6 months before first study drug administration
Who cannot join
- any personal or family history of epileptic seizures or convulsions
- have suffered from head trauma with loss of consciousness -have suffered from central nervous system infection
- have suffered from loss of consciousness of unknown origin
- drowning or sudden infant death syndrome in a first degree relative
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics Following Multiple Ascending Doses of Tramadol Hydrochloride in Healthy Male and Female Subjects
The purpose of this study is to determine the safety and tolerability profile of tramadol hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported by currently available toxicology and clinical data (200 mg to 600 mg per day).
Read the detailed description
This is a randomized (study drug assigned by chance), sequential-cohort (time lagged), double-blind (neither the participant or the study doctor will know the name of the assigned treatment), parallel-group, placebo-controlled, 3-arm (participants will be assigned to 1 of 3 treatment groups), single-center, Phase 1 study of multiple ascending doses of tramadol HCl in healthy adult volunteers. Thirty participants (15 men and 15 women) will be sequentially assigned to 1 of 3 treatment groups of 10 subjects each (5 men and 5 women). Participants in each treatment group will receive a total of 9 oral doses (one every 6 hours) of tramadol HCl or placebo, in the ratio of 4:1. The study includes a screening phase and a double-blind treatment phase. The treatment phase will consist of 3 treatment periods separated by a 5-day safety review period before the next ascending dose of study drug is administered to the next group. Participants in each group will be confined to the study center for a total of 5 days, the total duration of each subject's participation will be up to 33 days, including the screening phase. The total duration of the study (completion of all 3 treatment cohorts) will be up-to-approximately 2 months.
- Conditions
- Healthy
- Being tested
- Tramadol HCl, 50 mg, Placebo
- Keywords
- Healthy, Pain, Tramadol hydrochloride, Tramadol HCl, Analgesic, QT prolongation, RWJ-26898-002
- Medical subject headings
- Pain, Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HCl, 50 mgDrug
50-mg overencapsulated tablet for oral administration
PlaceboDrug
Size-matching capsules containing an appropriate inactive excipient
| Study group | Role | What they receive |
|---|---|---|
| 1: Tramadol HCl 200 mg daily or placebo | Experimental | Participants will receive one capsule of Tramadol hydrochloride (HCl) every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered. Receives: Drug: Tramadol HCl, 50 mg; Drug: Placebo |
| 2: Tramadol HCl 400 mg daily or placebo | Experimental | Participants will recieve two capsules of Tramadol HCl every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered. Receives: Drug: Tramadol HCl, 50 mg; Drug: Placebo |
| 3: Tramadol HCl 600 mg daily or placebo | Experimental | Participants will receive three capsules of Tramadol HCl every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered. Receives: Drug: Tramadol HCl, 50 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in vital signs and other parameters as a measure of safety and tolerability of tramadol
Changes in clinical laboratory results, vital signs, psycopharmacologic status (Richmond Agitation-Sedation Scale (RASS), and physical examination.
Measured: Baseline, Days 1 through 4
Secondary outcomes (3)
Change from baseline in time-matched electrocardiogram (ECG) measurements
ECG will detect abnormal changes from baseline in cardiac depolarization/repolarization.
Measured: Baseline, Day 1, Day 3 and Day 4
Change from baseline in pharmacokinetic parameters of tramadol and M1 metabolite
Determination of concentrations of tramadol and M1 metabolite pharmacokinetic parameters in venous plasma.
Measured: Baseline, up to 72 hours after the 1st dose
Incidence and type of adverse events
Measured: Baseline, till the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bausch Health Americas, Inc., Cipher Pharmaceuticals Inc.
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947920
- Sponsor's protocol ID
- CR102458
- Other IDs
- TRAMPAI1002, V01-TRAA-501, 2013-01-00
- Status last verified
- Dec 2014
- First submitted
- 13 Aug 2013
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics Following Multiple Ascending Doses of Tramadol Hydrochloride in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT01947920
- Acronym / sponsor ID
- CR102458
- Conditions
- Healthy
- Keywords
- Healthy, Pain, Tramadol hydrochloride, Tramadol HCl, Analgesic, QT prolongation, RWJ-26898-002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Bausch Health Americas, Inc., Cipher Pharmaceuticals Inc.
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Sep 2013 (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.
The purpose of this study is to determine the safety and tolerability profile of tramadol hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported by currently available toxicology and clinical data (200 mg to 600 mg per day).
Detailed description
This is a randomized (study drug assigned by chance), sequential-cohort (time lagged), double-blind (neither the participant or the study doctor will know the name of the assigned treatment), parallel-group, placebo-controlled, 3-arm (participants will be assigned to 1 of 3 treatment groups), single-center, Phase 1 study of multiple ascending doses of tramadol HCl in healthy adult volunteers. Thirty participants (15 men and 15 women) will be sequentially assigned to 1 of 3 treatment groups of 10 subjects each (5 men and 5 women). Participants in each treatment group will receive a total of 9 oral doses (one every 6 hours) of tramadol HCl or placebo, in the ratio of 4:1. The study includes a screening phase and a double-blind treatment phase. The treatment phase will consist of 3 treatment periods separated by a 5-day safety review period before the next ascending dose of study drug is administered to the next group. Participants in each group will be confined to the study center for a total of 5 days, the total duration of each subject's participation will be up to 33 days, including the screening phase. The total duration of the study (completion of all 3 treatment cohorts) will be up-to-approximately 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: Tramadol HCl 200 mg daily or placebo | Experimental | Drug: Tramadol HCl, 50 mg, Drug: PlaceboParticipants will receive one capsule of Tramadol hydrochloride (HCl) every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered. |
| 2: Tramadol HCl 400 mg daily or placebo | Experimental | Drug: Tramadol HCl, 50 mg, Drug: PlaceboParticipants will recieve two capsules of Tramadol HCl every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered. |
| 3: Tramadol HCl 600 mg daily or placebo | Experimental | Drug: Tramadol HCl, 50 mg, Drug: PlaceboParticipants will receive three capsules of Tramadol HCl every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- body mass index between 18 and 30 kg/m², inclusive
- body weight not less than 50 kg
- have a normal electroencephalogram under basic and stimulated conditions
- have a 12-lead ECG that is consistent with normal cardiac conduction and function
- have not used any tobacco products (eg, cigarettes, cigars, chewing tobacco, gum, or patch) for at least 6 months before first study drug administration
Key exclusion criteria (4 listed)
- any personal or family history of epileptic seizures or convulsions
- have suffered from head trauma with loss of consciousness -have suffered from central nervous system infection
- have suffered from loss of consciousness of unknown origin
- drowning or sudden infant death syndrome in a first degree relative
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 |
|---|---|---|
| Tramadol HCl, 50 mg50-mg overencapsulated tablet for oral administration | Drug | 1: Tramadol HCl 200 mg daily or placebo, 2: Tramadol HCl 400 mg daily or placebo, 3: Tramadol HCl 600 mg daily or placebo |
| PlaceboSize-matching capsules containing an appropriate inactive excipient | Drug | 1: Tramadol HCl 200 mg daily or placebo, 2: Tramadol HCl 400 mg daily or placebo, 3: Tramadol HCl 600 mg daily or placebo |
Primary outcome
Change from baseline in vital signs and other parameters as a measure of safety and tolerability of tramadol
Time frame: Baseline, Days 1 through 4
Changes in clinical laboratory results, vital signs, psycopharmacologic status (Richmond Agitation-Sedation Scale (RASS), and physical examination.
3 secondary outcomes
Change from baseline in time-matched electrocardiogram (ECG) measurements
Time frame: Baseline, Day 1, Day 3 and Day 4
Change from baseline in pharmacokinetic parameters of tramadol and M1 metabolite
Time frame: Baseline, up to 72 hours after the 1st dose
Incidence and type of adverse events
Time frame: Baseline, till the end of 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 Dec 2014.
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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.
Janssen Scientific Affairs, LLC Clinical trial study director
Janssen Scientific Affairs, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tramadol HCl, 50 mg in people with Healthy, run by Janssen Scientific Affairs, LLC 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 5 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: finished, as of the sponsor's last update on 16 Dec 2014. 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. 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 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.
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?
Change from baseline in vital signs and other parameters as a measure of safety and tolerability of tramadol (time frame: Baseline, Days 1 through 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 16 Dec 2014.