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Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic

An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Uncontrolled Severe Chronic Pain Due to Osteoarthritis of the Knee Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.

NCT00983073•Grünenthal GmbH

View on ClinicalTrials.gov

Summary

The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome. The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants have signed an Informed Consent Form indicating that they understand the purpose of and the procedures required for the trial and are willing to participate in it.
•2. Participants are men or non-pregnant, non-lactating women. Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. Women of childbearing potential must have a negative pregnancy test at screening.
•3. Participants must be appropriately communicative to verbalize and to differentiate with regard to location and intensity of the pain.
•4. Participants must be at least 40 years of age.
•5. Participants must have a diagnosis of osteoarthritis of the knee based on the American College of Rheumatology (ACR) classification criteria:
•* Knee pain and
•* Radiographic osteophytes or
•* Knee pain and
•* Aged 40 years or above, and
•* Morning stiffness of less than 30 minutes of duration and
+10 more criteria

Exclusion Criteria

•1. Presence of a clinically significant disease or laboratory findings that in the Investigator's opinion may affect efficacy or safety assessments.
•2. Presence of active systemic or local infection, that may, in the opinion of the Investigator, affect the efficacy, quality of life/function or safety assessments.
•3. History of alcohol or drug abuse, or suspicion thereof in the Investigator's judgment.
•4. Presence of concomitant autoimmune inflammatory conditions.
•5. Known history of or laboratory values reflecting severe renal impairment.
•6. Known history of moderately or severely impaired hepatic function.
•7. History of or active hepatitis B or C within the past 3 months or history of HIV infection.
•8. History of seizure disorder or epilepsy.
•9. Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post-traumatic amnesia lasting more than 24 h) or residual sequelae suggesting transient changes in consciousness.
•10. Pregnant or breast-feeding.
+16 more criteria

Locations (24)

Site 1

Belfort, France

Site 4

Marseille, France

Site 2

Murs Erigné, France

Site 3

Nantes, France

Site 5

Berlin, Germany

Site 2

Köln Dünnwald, Germany

Site 4

Leipzig, Germany

Site 6

Leipzig, Germany

Site 1

Marl, Germany

Site 3

Meine, Germany

Key Dates

Start Date

September 1, 2009

Primary Completion Date

June 1, 2010

Completion Date

September 1, 2010

Last Updated

October 21, 2019

Enrollment

224

ACTUAL participants

Conditions

Chronic PainOsteoarthritis

Interventions

Tapentadol

DRUG

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

NCT07153471

Osteoarthritis

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RECRUITINGPHASE1

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

NCT07351968

Moderate Pain in Knee OsteoarthritisSevere Pain in Knee Osteoarthritis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

General vs Spinal in Total Joint Arthroplasty (TJA)

CBD for Pain Following Orthopedic Shoulder Surgery

PENG Block Variants With Dexamethasone and Dexmedetomidine in Older Adults

A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression