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A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01947920
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : December 16, 2014
Sponsor:
Collaborators:
Bausch Health Americas, Inc.
Cipher Pharmaceuticals Inc.
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Brief 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).

Condition or disease Intervention/treatment Phase
Healthy Drug: Tramadol HCl, 50 mg Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1: Tramadol HCl 200 mg daily or placebo
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.
Drug: Tramadol HCl, 50 mg
50-mg overencapsulated tablet for oral administration

Drug: Placebo
Size-matching capsules containing an appropriate inactive excipient

Experimental: 2: Tramadol HCl 400 mg daily or placebo
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.
Drug: Tramadol HCl, 50 mg
50-mg overencapsulated tablet for oral administration

Drug: Placebo
Size-matching capsules containing an appropriate inactive excipient

Experimental: 3: Tramadol HCl 600 mg daily or placebo
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.
Drug: Tramadol HCl, 50 mg
50-mg overencapsulated tablet for oral administration

Drug: Placebo
Size-matching capsules containing an appropriate inactive excipient




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change from baseline in time-matched electrocardiogram (ECG) measurements [ Time Frame: Baseline, Day 1, Day 3 and Day 4 ]
    ECG will detect abnormal changes from baseline in cardiac depolarization/repolarization.

  2. Change from baseline in pharmacokinetic parameters of tramadol and M1 metabolite [ Time Frame: Baseline, up to 72 hours after the 1st dose ]
    Determination of concentrations of tramadol and M1 metabolite pharmacokinetic parameters in venous plasma.

  3. Incidence and type of adverse events [ Time Frame: Baseline, till the end of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947920


Locations
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United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Bausch Health Americas, Inc.
Cipher Pharmaceuticals Inc.
Investigators
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Study Director: Janssen Scientific Affairs, LLC Clinical trial Janssen Scientific Affairs, LLC

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Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01947920     History of Changes
Other Study ID Numbers: CR102458
TRAMPAI1002 ( Other Identifier: Janssen Scientific Affairs, LLC )
V01-TRAA-501 ( Other Identifier: Valeant Pharmaceuticals International Inc )
2013-01-00 ( Other Identifier: Cipher Pharmaceuticals Inc )
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014
Keywords provided by Janssen Scientific Affairs, LLC:
Healthy
Pain
Tramadol hydrochloride
Tramadol HCl
Analgesic
QT prolongation
RWJ-26898-002
Additional relevant MeSH terms:
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Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents