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- Klinische proef NCT01502644
Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
The level of high, moderate or low NA was determined based on the participant's score on the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-reported questionnaire that has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each item on the questionnaire is scored from 0 (least amount of anxiety/depression) to 3 (greatest amount of anxiety/depression), with total score between 0 and 21 for either anxiety or depression. Participants were assigned to high, moderate or low NA groups using the following HADS score criteria:
- High NA = HADS score ≥9 on each subscale
- Moderate NA = HADS score ≥6 to ≤8 on each subscale
- Low NA = HADS score ≤5 on each subscale
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Massachusetts
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Chestnut Hill, Massachusetts, Verenigde Staten, 02467
- Brigham and Women's Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Low Back Pain > 3/10
- Pain > 1 year
- Degenerative disc disease as seen on magnetic resonance imaging (MRI), which must meet minimum disc grading criteria: at least a grade III disc degeneration, a hyperintense zone, or abnormal disc morphology.
- Patients who may have had back surgery will be included.
- No epidural steroids or other nerve blocks for back pain either two weeks before or during the study period.
- No opioids or on short-acting opioids only (max. daily amount=120 mg morphine equivalents). It is not feasible to recruit only opioid naive patients.
- Must agree to 2-week washout for those on opioids.
- No active substance abuse.
- No intention to take new pain or psychiatric treatments during the study, including chiropractic, physical therapy, or complementary or alternative treatments (CAM). It is not feasible to take participants off of any other pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDS).
- No pregnancy or the intent to become pregnant during the study, and no nursing mothers.
- Women, who are able to bear children, must agree to use contraceptives throughout the study.
- In men, normal baseline testosterone levels.
Exclusion Criteria:
- Patients with pain due to disorders not including a component of disc degeneration, or those with unknown causes of pain will be excluded.
- Patients with the intent to undergo back surgery will be excluded.
- Patients with a history of recent or ongoing alcohol or other drug addiction disorders will be excluded.
- Patients with any history of substance abuse of opioids will be excluded.
- Patients whose diagnosis cannot be firmly established according to criteria described above would not be included.
- Patients whose medical and psychiatric comorbidities are not well controlled, or who are currently experiencing an acute exacerbation of the medical comorbidity, will be excluded.
- Males with abnormal testosterone levels will be excluded (normal range is 1800-6650 pg/ml).
- Female patients who nursing will be excluded.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Low Negative Affect (NA)
Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
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Daily dosage up to 120 mg
Daily dosage up to 90 mg immediate release or 180 mg extended release
Andere namen:
Placebo-matching oxycodone, placebo-matching morphine
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Actieve vergelijker: Moderate NA
Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
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Daily dosage up to 120 mg
Daily dosage up to 90 mg immediate release or 180 mg extended release
Andere namen:
Placebo-matching oxycodone, placebo-matching morphine
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Actieve vergelijker: High NA
Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
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Daily dosage up to 120 mg
Daily dosage up to 90 mg immediate release or 180 mg extended release
Andere namen:
Placebo-matching oxycodone, placebo-matching morphine
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percent Change in Average Daily Pain Score
Tijdsspanne: Baseline and Week 20
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Participants rated their average lower back pain over the past 24 hours using an 11-point scale (0=no pain to 10=worst possible pain) and recorded it in an electronic diary.
The percent change in pain score from baseline is calculated using weekly averages for up to 20 weeks.
Linear mixed modeling (LMM) analysis was used to allow for inclusion in the analysis of the majority of participants with any missing data.
For the LMM model, group, group × week, average baseline pain, and opioid use at baseline (yes/no) were entered as fixed effects using an autoregressive covariance structure.
Participant, intercept, and week were entered as random effects, using a compound symmetry covariance structure.
A positive change from baseline indicates an improvement.
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Baseline and Week 20
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ajay D Wasan, MD, MSc, Brigham and Women's Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pijn
- Neurologische manifestaties
- Musculoskeletale aandoeningen
- Spinale ziekten
- Botziekten
- Rugpijn
- Onderrug pijn
- Degeneratie van tussenwervelschijven
- Fysiologische effecten van medicijnen
- Depressiva van het centrale zenuwstelsel
- Agenten van het perifere zenuwstelsel
- Pijnstillers
- Sensorische systeemagenten
- Pijnstillers, opioïden
- Verdovende middelen
- Morfine
- Oxycodon
Andere studie-ID-nummers
- 2007P-001047
- 5K23DA020681-05 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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