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Duloxetine Versus Placebo in Chronic Low Back Pain

18 novembre 2009 mis à jour par: Eli Lilly and Company

Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain

The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition.

Whether duloxetine once daily can help patients with Chronic Low Back Pain.

Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

236

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Ellwangen, Allemagne, 73479
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Graefelfing, Allemagne, 82166
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Hamburg, Allemagne, 22143
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Wiesbaden, Allemagne, 65191
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
  • Brésil
      • Curitiba, Brésil, 80060240
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • San Paulo, Brésil, 04027-000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Sao Paulo, Brésil, 04026-000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
  • France
      • Amiens, France, 80054
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Marseille, France, 13008
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Paris, France, 75014
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Saint Affrique, France, 12400
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Saint-Etienne, France, 42055
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
  • Mexique
      • Mexico City, Mexique, 06700
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Monterrey, Mexique, 64460
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • San Pedro Garza Garcia, Mexique, 66260
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
  • Pays-Bas
      • Amsterdam, Pays-Bas, 1105 AZ
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Rotterdam, Pays-Bas, 3039 BD
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Male/Female outpatients 18 years of age with chronic low back pain
  • Females of child bearing potential must test negative on a pregnancy test at visit 1.

Exclusion Criteria:

  • Have a serious or unstable diseases of the heart or blood vessels, liver, kidney, lungs, or blood-related illness
  • Problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions
  • Psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study
  • Have acute liver injury (such as hepatitis) or severe cirrhosis
  • Have had previous exposure to duloxetine
  • Have a body mass index (BMI) over 40
  • Have a major depressive disorder
  • Require daily narcotics
  • Have suicidal risk
  • Have a presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Duloxetine
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
Médicament: Duloxetine
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
Autres noms:
  • Cymbalte
  • LY248686
Comparateur placebo: Placebo
every day (QD), by mouth (PO), 13 weeks
Médicament: Placebo
every day (QD), by mouth (PO), 13 weeks

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores
Délai: Baseline, Week 13
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Baseline, Week 13

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patient's Global Impression of Improvement (PGI-I)
Délai: Week 13
A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).
Week 13
Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score
Délai: Baseline, Week 13, Week 54
Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Baseline, Week 13, Week 54
Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale
Délai: Baseline, Week 13
24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items.
Baseline, Week 13
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Délai: Baseline, Week 13, Week 54
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.
Baseline, Week 13, Week 54
Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)
Délai: Baseline, Week 13, Week 54
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Baseline, Week 13, Week 54
Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria
Délai: Week 13
Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.
Week 13
Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria
Délai: Week 13
Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.
Week 13
Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale
Délai: Baseline, Week 13, Week 54
Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.
Baseline, Week 13, Week 54
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Délai: Baseline, Week 13
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.
Baseline, Week 13
Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)
Délai: Baseline, Week 13
The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. Scores presented used the UK Based Index Score.
Baseline, Week 13
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Délai: Baseline, Week 13, Week 54

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment.

  1. Absenteeism=(Q2/(Q2+Q4))*100
  2. Presenteeism=(Q5/10)*100
  3. Work productivity loss=(Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)])*100
  4. Activity Impairment=(Q6/10)*100
Baseline, Week 13, Week 54
Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores
Délai: Baseline, Week 13, Week 54
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Baseline, Week 13, Week 54
Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores
Délai: Baseline, Week 13
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Baseline, Week 13
Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate
Délai: Baseline, Week 13
Baseline, Week 13
Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid
Délai: Baseline, Week 13
Baseline, Week 13
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate
Délai: Baseline, Week 13, Week 54
Baseline, Week 13, Week 54
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure
Délai: Baseline, Week 13, Week 54
Baseline, Week 13, Week 54
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight
Délai: Baseline, Week 13, Week 54
Baseline, Week 13, Week 54

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Serious Adverse Events During the Dose-Blind Extension Phase
Délai: Week 13 though Week 54
Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.
Week 13 though Week 54
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase
Délai: Week 13 through Week 54
Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.
Week 13 through Week 54

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Eli Lilly and Company

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2007

Achèvement primaire (Réel)

1 décembre 2007

Achèvement de l'étude (Réel)

1 octobre 2008

Dates d'inscription aux études

Première soumission

17 janvier 2007

Première soumission répondant aux critères de contrôle qualité

17 janvier 2007

Première publication (Estimation)

19 janvier 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

20 novembre 2009

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 novembre 2009

Dernière vérification

1 novembre 2009

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 10544 (Autre identifiant: Fred Hutch/University of Washington Cancer Consortium)
  • F1J-MC-HMEN

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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