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A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 13, 2013
First Posted Date  ICMJE September 23, 2013
Last Update Posted Date December 16, 2014
Study Start Date  ICMJE August 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2013)
  • 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.
  • 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.
  • Incidence and type of adverse events [ Time Frame: Baseline, till the end of study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers
Official Title  ICMJE 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
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Tramadol HCl, 50 mg
    50-mg overencapsulated tablet for oral administration
  • Drug: Placebo
    Size-matching capsules containing an appropriate inactive excipient
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Tramadol HCl, 50 mg
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Tramadol HCl, 50 mg
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Tramadol HCl, 50 mg
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01947920
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Scientific Affairs, LLC
Study Sponsor  ICMJE Janssen Scientific Affairs, LLC
Collaborators  ICMJE
  • Bausch Health Americas, Inc.
  • Cipher Pharmaceuticals Inc.
Investigators  ICMJE
Study Director: Janssen Scientific Affairs, LLC Clinical trial Janssen Scientific Affairs, LLC
PRS Account Janssen Scientific Affairs, LLC
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP