HealthyPhase 1NCT00834912

Study of Two Tramadol Contramid® OAD 300 mg Controlled-Release Tablets From Two Different Manufacturing Sites Following a 300 mg Dose in Healthy Subjects Under Fasting and Fed Conditions

A Phase 1 study testing Tramadol hydrochloride and Tramadol HCl in people with Healthy, run by Labopharm Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this study is to compare the rate and extent of absorption of two Tramadol Contramid® OAD 300 mg controlled-release tablets from two different manufacturing sites, administered as 1 x 300 mg controlled-release tablet under fasting conditions. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Tramadol hydrochloride and Tramadol HCl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: No sites listed yet
Study dates: Feb 2006to Apr 2006
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female, non-smoker, ≥18 and ≤55 years of age.
Capable of consent.
Body Mass Index (BMI) ≥19.0 and <30.0 kg/m2.

Who cannot join

Clinically significant illness or surgery within 4 weeks prior to dosing.
Any clinically significant abnormality or abnormal laboratory test results found during medical screening.
Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
Positive test for hepatitis B, hepatitis C, or HIV at screening.
Electrocardiogram (ECG) abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 beats per minute [bpm]) at screening.
History of significant alcohol abuse or drug abuse within one year prior to the screening visit.

Show all 34Show fewer

Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
History of allergic reactions to tramadol or other related drugs.
Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (Selective serotonin reuptake inhibitors [SSRIs]), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
Use of an investigational drug or participation in an investigational study within 30 days prior to dosing.
Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
Any clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption and hormonal contraceptives.
Difficulty to swallow study medication.
Use of any tobacco products in the 3 months preceding drug administration.
Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
A depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to administration of study medication.
Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
50 mL to 499 mL of whole blood within 30 days,
more than 499 mL of whole blood within 56 days prior to drug administration.
Consumption of food or beverages containing grapefruit (e.g. fresh, canned, or frozen) within 7 days prior to administration of the study medication.
History or presence of substance addiction.
History of anaphylactoid reactions to codeine and other opioids.
History of respiratory depression.
History of increased intracranial pressure or head injury.
History or presence of asthma, chronic obstructive pulmonary disease or other pulmonary condition that may predispose to hypoventilation.
Opioid consumption in the 3 months preceding drug administration or history of drug dependence to any opioids.
Positive urine pregnancy test at screening.
Breast-feeding subject.
Female subjects of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration. Acceptable methods of contraception are:
intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration;
condom or diaphragm + spermicide;
hormonal contraceptives (starting at least 4 weeks prior to study drug administration).

About this study

Conditions: Healthy
Being tested: Tramadol hydrochloride, Tramadol HCl
Keywords: Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tramadol hydrochlorideDrug
1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.
Tramadol HClDrug
1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fed condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.
Tramadol HClDrug
1x300mg Tramadol Hydrochloride (HCl) tablet (Trillium Healthcare) fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.

Study groups in NCT00834912
Study group	Role	What they receive
1: Tramadol HCl (Confab Laboratories) fasting	Experimental	Not described Receives: Drug: Tramadol hydrochloride
2: Tramadol HCl (Confab Laboratories) fed	Experimental	Not described Receives: Drug: Tramadol HCl
3: Tramadol HCl (Trillium Healthcare) fasting	Experimental	Not described Receives: Drug: Tramadol HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC(0-t)
Area under the plasma concentration (AUC) versus time curve to the last measurable concentration.
Measured: 48 hours
AUC(0-∞)
The area under the plasma concentration (AUC) curve was estimated by extrapolating to infinity AUC0-t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R'2 (coefficient of determination). The units are ng.h/mL.
h=hours
Measured: 48 hours
Cmax
Maximum plasma concentration (Cmax)
Measured: 48 hours

Secondary outcomes (2)

Tmax
Time to maximum plasma concentration (Tmax)
Measured: 48 hours
t1/2
Apparent terminal elimination half-life (t1/2)
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006Apr 2006

First posted3 Feb 2009 (estimated)
Study startFeb 2006
Primary completionApr 2006
Study completionApr 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00834912
Sponsor's protocol ID: MDT1-016
Status last verified: Apr 2012
First submitted: 30 Jan 2009
Last updated: 30 Apr 2012
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Two Tramadol Contramid® OAD 300 mg Controlled-Release Tablets From Two Different Manufacturing Sites Following a 300 mg Dose in Healthy Subjects Under Fasting and Fed Conditions
ClinicalTrials.gov ID: NCT00834912
Acronym / sponsor ID: MDT1-016
Conditions: Healthy
Keywords: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Labopharm Inc.Industry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Apr 2006 (actual)
Study completion: Apr 2006 (actual)
First posted: 3 Feb 2009 (estimated)
Results: Posted 19 Oct 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1: Tramadol HCl (Confab Laboratories) fasting	Experimental	Drug: Tramadol hydrochloride
2: Tramadol HCl (Confab Laboratories) fed	Experimental	Drug: Tramadol HCl
3: Tramadol HCl (Trillium Healthcare) fasting	Experimental	Drug: Tramadol HCl

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Male or female, non-smoker, ≥18 and ≤55 years of age.
Capable of consent.
Body Mass Index (BMI) ≥19.0 and <30.0 kg/m2.

Key exclusion criteria (34 listed)

Clinically significant illness or surgery within 4 weeks prior to dosing.
Any clinically significant abnormality or abnormal laboratory test results found during medical screening.
Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
Positive test for hepatitis B, hepatitis C, or HIV at screening.
Electrocardiogram (ECG) abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 beats per minute [bpm]) at screening.

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 hydrochloride1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.	Drug	1: Tramadol HCl (Confab Laboratories) fasting
Tramadol HCl1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fed condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.	Drug	2: Tramadol HCl (Confab Laboratories) fed
Tramadol HCl1x300mg Tramadol Hydrochloride (HCl) tablet (Trillium Healthcare) fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.	Drug	3: Tramadol HCl (Trillium Healthcare) fasting

Primary outcome

AUC(0-t)
Time frame: 48 hours
Area under the plasma concentration (AUC) versus time curve to the last measurable concentration.
AUC(0-∞)
Time frame: 48 hours
The area under the plasma concentration (AUC) curve was estimated by extrapolating to infinity AUC0-t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R'2 (coefficient of determination). The units are ng.h/mL. h=hours
Cmax
Time frame: 48 hours
Maximum plasma concentration (Cmax)

2 secondary outcomes

Tmax
Time frame: 48 hours
t1/2
Time frame: 48 hours

Results and safety

Results posted to the registry on 19 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Confab Fasting / Confab Fed / Trillium Fasting	6	6
Confab Fasting / Trillium Fasting / Confab Fed	6	5
Confab Fed / Confab Fasting / Trillium Fasting	6	6
Confab Fed / Trillium Fasting / Confab Fasting	6	5
Trillium Fasting / Confab Fasting / Confab Fed	6	6
Trillium Fasting / Confab Fed / Confab Fasting	6	6

Primary outcome: AUC(0-t)

Time frame: 48 hours. Mean (Standard Deviation). Unit: ng.h/mL

Measure	1: Tramadol HCl 300 mg (Confab Laboratories) Fasting n = 34	2: Tramadol HCl 300 mg (Confab Laboratories) Fed n = 33	3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting n = 33
Value	9708 (3875)	9696 (3750)	9431 (3225)

Population analysed: Data from all randomized subjects who completed at least 2 periods of the study are presented.

Primary outcome: AUC(0-∞)

Time frame: 48 hours. Mean (Standard Deviation). Unit: ng.h/mL

Measure	1: Tramadol HCl 300 mg (Confab Laboratories) Fasting n = 33	2: Tramadol HCl 300 mg (Confab Laboratories) Fed n = 33	3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting n = 33
Value	9882 (3933)	9898 (3970)	10095 (4070)

Population analysed: Data from all randomized subjects who completed at least 2 periods of the study are presented. The pharmacokinetic variables AUC(0-∞) of one subject for Tramadol HCl 300 mg (Confab Laboratories) fasting were not used in the analyses due to the morphology of the plasma concentration-time curves.

Primary outcome: Cmax

Time frame: 48 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	1: Tramadol HCl 300 mg (Confab Laboratories) Fasting n = 34	2: Tramadol HCl 300 mg (Confab Laboratories) Fed n = 33	3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting n = 33
Value	433 (206)	728 (317)	402 (201)

Population analysed: Data from all randomized subjects who completed at least 2 periods of the study are presented.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1: Tramadol HCl 300 mg (Confab Laboratories) Fasting	0 of 36 (0%)	27 of 36 (75%)	Not reported
2: Tramadol HCl 300 mg (Confab Laboratories) Fed	0 of 36 (0%)	27 of 36 (75%)	Not reported
3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting	0 of 36 (0%)	19 of 36 (52.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Approved labellingLink provided by the sponsor.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tramadol hydrochloride and Tramadol HCl in people with Healthy, run by Labopharm Inc..

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 3 inclusion and 34 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 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 19 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

AUC(0-t) (time frame: 48 hours). The study lists 3 primary outcomes in all. 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 NCT00834912.

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 30 Apr 2012.