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AzTrials

Chronic PainPhase 3NCT00983385

Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics

A Phase 3 study testing Tapentadol PR and Observation period in people with Chronic Pain and Low Back Pain, run by Grünenthal GmbH at 46 sites in 9 countries.

Completed

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

Official record
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Trial summary

The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking either WHO Step I or Step II analgesics or no regular analgesics. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain, Low Back Pain
What is being tested?
Tapentadol PR and Observation period
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
46 sitesin 9 countries
Study dates
30 Sep 2009to 6 Jul 2010
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have signed an Informed Consent Form.
  • Participants were men or non-pregnant, non-lactating women. Female participants must be postmenopausal, surgically sterile, or practicing an effective method of birth control. Women of childbearing potential must have a negative pregnancy test at screening.
  • Participants must be appropriately communicative to verbalize and to differentiate with regard to location and intensity of the pain.
  • Participants must be at least 18 years of age.
  • Participants must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months.
  • If the participant has radicular pain, this must have been present for at least 3 months and stable for the 4 weeks before enrollment.
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  • Participants's pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator.
  • Participants must report a rate of satisfaction with their previous analgesic regimen not exceeding "fair" on a subject satisfaction with treatment scale (5-point VRS).
  • If under regular, daily pretreatment:
  • Participants must be taking a WHO Step I or Step II analgesic medication on a daily basis for at least 2 weeks prior to the Screening Visit.
  • The Investigator considers dose increase of WHO Step I analgesics (as mono- or combination therapy) and/or continuation with or dose increase of WHO Step II analgesics inadequate for the individual participant, whatever applicable.
  • Participants must have an average pain intensity score (NRS 3) greater than 5 points during the last 3 days prior to the Screening Visit. or
  • If no regular analgesic pretreatment is reported:
  • Participants must have an average pain intensity score (NRS-3) greater than 6 points in the last 3 days prior to the Screening Visit and related to low back pain.

Who cannot join

  • Presence of a clinically significant disease or laboratory findings that in the Investigator's opinion may affect efficacy or safety assessments.
  • 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.
  • History of alcohol or drug abuse, or suspicion of in Investigator's judgement.
  • Presence of concomitant autoimmune inflammatory conditions.
  • Known history of or laboratory values reflecting severe renal impairment.
  • Known history of moderately or severely impaired hepatic function.
Show all 23Show fewer
  • History of or active hepatitis B or C within the past 3 months or history of HIV infection
  • History of seizure disorder or epilepsy.
  • 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.
  • Pregnant or breast-feeding.
  • History of allergy to, or hypersensitivity to tapentadol hydrochloride or its excipients, or contraindications related to tapentadol hydrochloride including:
  • Participants with acute or severe bronchial asthma or hypercapnia.
  • Participants who have or are suspected of having paralytic ileus.
  • Employees of the Investigator or trial site, with direct involvement in this trial or other trials under the direction of the Investigator or trial site, as well as family members of employees of the Investigator.
  • Participation in another trial concurrently or within 4 weeks prior to the Screening Visit.
  • Known to or suspected of not being able to comply with the protocol and the use of the investigational medicinal product.
  • Use of monoamine oxidase inhibitors within 14 days before the Screening Visit.
  • Non-stable dosing of selective serotonin reuptake inhibitors within 30 days before the Screening Visit (the doses must remain stable during the trial).
  • Presence of conditions other than low back pain that could confound the assessment or self evaluation of pain, e.g., anatomical deformities, significant skin conditions such as abscess or syndromes with widespread pain such as fibromyalgia.
  • Any concomitant painful condition that could interfere with the subject's trial assessments or with their ability to differentiate low back pain from other painful conditions.
  • Any painful procedures during the trial (e.g., major surgery) that may, in the opinion of the Investigator, affect the efficacy or safety assessments.
  • Pending litigation due to chronic pain or disability.
  • Intake of Step III analgesics within the 30 days prior to the Screening Visit.

Trial locations and contacts

46 sites in 9 countries.

46 sites in 9 countries

Germany8 sites

  • Site 3

    Berlin

  • Site 7

    Böblingen

  • Site 4

    Celle

  • Site 1

    Dresden

  • Site 6

    Hanover

  • Site 8

    Leipzig

  • Site 5

    Lünen

  • Site 2

    Wiesbaden

Other trials in Germany

United Kingdom8 sites

  • Site 7

    Belfast

  • Site 2

    Bristol

  • Site 8

    Chelmsford

  • Site 6

    Edinburgh

  • Site 1

    Glasgow

  • Site 4

    London

  • Site 5

    London

  • Site 3

    Plymouth

Other trials in United Kingdom

Spain7 sites

  • Site 5

    Alicante

  • Site 1

    Badalona

  • Site 7

    Guadalajara

  • Site 6

    Madrid

  • Site 4

    Oviedo

  • Site 8

    Pamplona

  • Site 3

    Valencia

Other trials in Spain

Italy6 sites

  • Site 6

    Bologna

  • Site 5

    Catania

  • Site 2

    Genova

  • Site 4

    Parma

  • Site 3

    Pavia

  • Site 1

    Rome

Other trials in Italy

Austria5 sites

  • Site 5

    Graz

  • Site 1

    Vienna

  • Site 2

    Vienna

  • Site 3

    Vienna

  • Site 4

    Vienna

Other trials in Austria

France4 sites

  • Site 2

    Châteaugiron

  • Site 4

    La Seyne-sur-Mer

  • Site 3

    Murs Erigné

  • Site 1

    Paris

Other trials in France

Croatia3 sites

  • Site 3

    Karlovac

  • Site 2

    Opatija

  • Site 1

    Sisak

Other trials in Croatia

Poland3 sites

  • Site 1

    Lublin

  • Site 4

    Tychy

  • Site 3

    Wroclaw

Other trials in Poland

Switzerland2 sites

  • Site 1

    Morges

  • Site 2

    Valens

Other trials in Switzerland

About this study

Official title: 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 Nociceptive, Mixed or Neuropathic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.

The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) 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.

Being tested
Tapentadol PR, Observation period
Keywords
low back pain, pain, assessment, tapentadol, centrally acting analgesic
Medical subject headings
Chronic Pain, Low Back Pain, Pain

What participants receive

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

  • Tapentadol PRDrug

    Also called Palexia®, Nucynta®

    Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg Tapentadol PR twice daily, adjusted with 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed a dose of 500 mg of Tapentadol per day.

  • Observation periodOther

    Eligibility assessment period to characterize the baseline over a one week period (week -1). Participants continued their previous treatment prior to allocation to tapentadol, if eligible.

  • Tapentadol PRDrug

    Also called Palexia®, Nucynta®

    Maintenance Period: In this period participants continued Tapentadol Prolonged Release (PR) on the dose established in the Titration and Optimal Dose Period. Tapentadol IR participants were not permitted to exceed a total daily tapentadol dose of 500 mg.

Study groups in NCT00983385
Study groupRoleWhat they receive
TapentadolExperimentalTapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol immediate release (IR) tablets per day, with a minimum of a 4 hour interval between doses, were taken if there were acute pain episodes. The total daily dose of Tapentadol PR and IR were not permitted to exceed 500 mg per day.
Receives: Drug: Tapentadol PR; Other: Observation period

What is being measured

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

  1. The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline).

    For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity.

    Measured: Baseline; End of Week 6 (6 Weeks)

Secondary outcomes (35)

  1. Patient Global Impression of Change at End of Titration and Optimal Dose Period

    In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.

    Measured: Baseline; End of Week 6 (6 Weeks)

  2. Patient Global Impression of Change at End of the Maintenance Period

    In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.

    Measured: Baseline; End of Week 12 (12 weeks)

  3. Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period

    The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.

    Measured: Baseline; End of Week 6 (6 weeks)

  4. Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period

    The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.

    Measured: Baseline; End of Week 12 (12 weeks)

  5. painDETECT Assessment at Baseline

    The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being "negative" (no neuropathic pain component). Value between 19 and 38 as being "positive" (presence of neuropathic component)". Values from 13 to 18 are scored as being "unclear".

    Measured: Baseline

  6. painDETECT Assessment for Participants at End of Titration and Optimal Dose Period

    The baseline painDETECT score was reassessed at the end of Week 6.

    It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being "negative" (no neuropathic pain component). Value between 19 and 38 as being "positive" (presence of neuropathic component)". Values from 13 to 18 are scored as being "unclear".

    Measured: End of Week 6

  7. painDETECT Assessment for Participants at End of the Maintenance Period

    The baseline painDETECT score was reassessed at the end of Week 12.

    It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being "negative" (no neuropathic pain component). Value between 19 and 38 as being "positive" (presence of neuropathic component)". Values from 13 to 18 are scored as being "unclear".

    Measured: End of Week 12

  8. Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline

    Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.

    Measured: Baseline Visit

  9. Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period

    Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.

    Measured: End of Week 6

  10. Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period

    Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.

    Measured: End of Week 12

  11. Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of Titration and Optimal Dose Period

    Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.

    Measured: Baseline; End of Week 6 (6 Weeks)

  12. Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of the Maintenance Period

    Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.

    Measured: Baseline; End of Week 12 (12 Weeks)

  13. EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period.

    The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. The positive values indicate that during the study the health status improved.

    Measured: Baseline; End of Week 6 (6 weeks)

  14. Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period.

    EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.

    Measured: Baseline; End of Week 6 (6 weeks)

  15. EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period

    The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. The positive values indicate that during the study the health status improved.

    Measured: Baseline; End of Week 12 (12 weeks)

  16. Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period

    EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.

    Measured: Baseline; End of Week 12 (12 weeks)

  17. Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period

    In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.

    Measured: Baseline; End of Week 6 (6 weeks)

  18. Clinical Global Impression of Change (All Participants) at End of Maintenance Period

    In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.

    Measured: Baseline; End of Week 12 (12 weeks)

  19. Hospital Anxiety Depression Scale (HADS): Anxiety Score at Baseline

    Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.

    HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.

    A negative value indicates that there has been an improvement.

    Measured: Baseline

  20. Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period

    Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.

    HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.

    A negative value indicates that there has been an improvement.

    Measured: Baseline; End of Week 6 (6 weeks)

  21. Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period

    Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.

    HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.

    A negative value indicates that there has been an improvement.

    Measured: Baseline; End of Week 12 (12 Weeks)

  22. Hospital Anxiety Depression Scale: Depression Score at Baseline

    Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.

    HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.

    A negative value indicates that there has been an improvement.

    Measured: Baseline

  23. Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period.

    Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.

    HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.

    A negative value indicates that there has been an improvement.

    Measured: Baseline; End of Week 6 (6 weeks)

  24. Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period

    Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.

    HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.

    A negative value indicates that there has been an improvement.

    Measured: Baseline; End of Week 12 (12 Weeks)

  25. Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period.

    Tapentadol hydrochloride PR dose after 5 weeks of titration which was to be kept stable during the remained of the trial.

    Measured: Week 6

  26. Participant's Satisfaction With Previous Analgesic Treatment at Baseline

    Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous analgesic medication was rated as excellent, very good, good, fair and poor.

    Measured: Baseline

  27. Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period.

    Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.

    Measured: End of Week 6

  28. Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period.

    Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.

    Measured: End of Week 8

  29. Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period.

    Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.

    Measured: End of Week 12

  30. Baseline NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment, at Baseline.

    For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".

    Measured: Baseline

  31. NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.

    For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".

    Measured: End of Week 6

  32. NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Maintenance Period.

    For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".

    Measured: End of Week 12

  33. Baseline NRS-3 Pain Intensity in Participants With Prior Opioid Treatment, at Baseline.

    For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".

    Measured: Baseline

  34. NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.

    For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".

    Measured: End of Week 6

  35. NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Maintenance Period.

    For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".

    Measured: End of Week 12

Timeline

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

  1. First posted24 Sep 2009 (estimated)
  2. Study start30 Sep 2009
  3. Primary completionMay 2010
  4. Study completion6 Jul 2010

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00983385
Sponsor's protocol ID
787579
Other IDs
2009-010427-12, KF5503/44, 2009
Status last verified
Dec 2018
First submitted
23 Sep 2009
Last updated
15 Jan 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Information available on the Grünenthal Web Site

Publications

  • Steigerwald I, Muller M, Davies A, Samper D, Sabatowski R, Baron R, Rozenberg S, Szczepanska-Szerej A, Gatti A, Kress HG. Effectiveness and safety of tapentadol prolonged release for severe, chronic low back pain with or without a neuropathic pain component: results of an open-label, phase 3b study. Curr Med Res Opin. 2012 Jun;28(6):911-36. doi: 10.1185/03007995.2012.679254. Epub 2012 May 9.

    PubMed 22443293

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tapentadol PR and Observation period in people with Chronic Pain and Low Back Pain, run by Grünenthal GmbH at 46 sites in 9 countries.

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 14 inclusion and 23 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Germany, United Kingdom, Spain, Italy, Austria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Apr 2012). 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?

The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline). (time frame: Baseline; End of Week 6 (6 Weeks)). 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 NCT00983385, which also lists 1 linked publication.

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 15 Jan 2019.

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