NCT00833794

Brief Summary

The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit of Tramadol OAD tablets versus Placebo.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,028

participants targeted

Target at P75+ for phase_3 pain

Timeline
Completed

Started Oct 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
6 months until next milestone

Results Posted

Study results publicly available

August 10, 2009

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

1.3 years

First QC Date

January 29, 2009

Results QC Date

April 9, 2009

Last Update Submit

April 25, 2012

Conditions

PainOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)

    The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain. The mean score at the end of the study (week 12 or time of discontinuation) was calculated.

    12 weeks

Secondary Outcomes (9)

  • Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment

    6 weeks

  • Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)

    12 weeks

  • WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)

    12 weeks

  • WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)

    12 weeks

  • Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)

    12 weeks

  • +4 more secondary outcomes

Study Arms (2)

1 Tramadol Once A Day

EXPERIMENTAL
Drug: Tramadol Once a day

2 Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Tramadol Once a dayDRUG
1 Tramadol Once A Day
PlaceboDRUG
2 Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females
  • Must be between the ages of 40-80
  • Must meet the American College of Rheumatology (ACR) Clinical Classification Criteria for Osteoarthritis of the Knee:
  • Current knee pain
  • Less than 30 minutes of morning stiffness with or without crepitus on active motion
  • Confirmation either by arthroscopy or radiologist's report (X-rays showing osteophytes, joint space narrowing or subchondral bone sclerosis {eburnation}) within five years prior to entry into the study
  • Must have a history of exposure to treatment (for pain due to osteoarthritis (OA) of the knee) with Non-steroidal anti-inflammatory drugs (NSAIDs), COX II inhibitors or tramadol.
  • Must be taking one of the above medications on a regular basis in the 30 days prior to Visit 2 (S0).
  • Must meet the following criteria for severity of pain at Visit 2 (Day S0):
  • Have a score of ≥ 4 on the 11-point Numerical Rating Scale (PI-NRS; range: 0-10)
  • Have a total increase of ≥ 2 points on the 11-point Numerical Rating Scale (range: 0-10) compared to the rating at Visit 1 (Day SX)
  • Must have a erythrocyte sedimentation rate (ESR) \< 40 mm/hr
  • Must have oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials
  • Must have signed and dated an approved written Informed Consent form in French, Spanish, English or Romanian, which has also been signed and dated by the Investigator (unless otherwise required by the ethics committee), prior to study participation

You may not qualify if:

  • Has known rheumatoid arthritis or any other rheumatic disease
  • Has secondary arthritis i.e. any of the following: septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; target joint fracture; acromegaly; fibromyalgia; Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis; heritable arthritic disorders; or collagen gene mutations
  • Has a history of bursitis of the knee (target knee)
  • Has a history of pain in the ipsilateral hip (target knee)
  • Has had a meniscal tear in the target knee within the last 12 months
  • Has had cartilage reconstruction procedure in the target knee
  • Has had a therapeutic arthroscopy procedure in the target knee within the last 12 months
  • Has a Body Mass Index (BMI) greater than 37
  • Has had a major illness, requiring hospitalisation during the 3 months before commencement of the screening period
  • Is unwilling to stop taking pain medication other than the study medication (for arthritis or other types of pain) or is unwilling to stop taking other medications for the treatment of OA
  • Has previously failed treatment with tramadol or discontinued treatment with tramadol due to adverse events
  • Has been taking other opioids (e.g. codeine, oxycodone, hydromorphone, etc.) for treatment of OA or other chronic conditions
  • Has received Corticosteroid Injections in the target knee within the last 3 months or Viscous injections in the target knee within the last 6 months
  • Has had treatment within the last 3 weeks with any of the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors; serotonin-norepinephrine reuptake inhibitors or any other drug that reduces seizure threshold
  • Has had treatment with another investigational agent within the last 30 days
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Burch F, Fishman R, Messina N, Corser B, Radulescu F, Sarbu A, Craciun-Nicodin MM, Chiriac R, Beaulieu A, Rodrigues J, Beignot-Devalmont P, Duplan A, Robertson S, Fortier L, Bouchard S. A comparison of the analgesic efficacy of Tramadol Contramid OAD versus placebo in patients with pain due to osteoarthritis. J Pain Symptom Manage. 2007 Sep;34(3):328-38. doi: 10.1016/j.jpainsymman.2006.11.017. Epub 2007 Jun 21.

    PMID: 17583466RESULT

Related Links

MeSH Terms

Conditions

PainOsteoarthritis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Director of Regulatory Affairs
Organization
Labopharm Inc.
1 450 686 1017

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2009

First Posted

February 2, 2009

Study Start

October 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

April 30, 2012

Results First Posted

August 10, 2009

Record last verified: 2012-04