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Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain.
Curr Med Res Opin. 2010 Jun; 26(6):1505-18.CM

Abstract

OBJECTIVE

This multicenter, double-blind, placebo-controlled study using a randomized withdrawal design evaluated the efficacy and safety of once-daily OROS hydromorphone ER in the treatment of opioid-tolerant patients with chronic moderate-to-severe low back pain (LBP).

MAIN OUTCOME MEASURES

The primary efficacy assessment was mean change in pain intensity based on patient diary Numeric Rating Scale (NRS) scores from baseline to final visit of the 12-week double-blind phase. Secondary endpoints included mean change from baseline to each visit in patient diary NRS scores; and office NRS scores; time to treatment failure; Patient Global Assessment; rescue medication use; and Roland Morris Disability Questionnaire total scores.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov NCT00549042.

RESULTS

For the primary outcome measure, hydromorphone ER significantly reduced pain intensity compared to placebo (p < 0.001). Median diary NRS score change from baseline to endpoint was significantly lower for OROS [corrected] hydromorphone ER (0.2 units) compared to placebo (1.6 units). [corrected] A significantly higher proportion of hydromorphone ER (60.6%) vs. placebo (42.9%) patients had at least a 30% reduction in diary NRS pain score from screening to endpoint (p < 0.01). Hydromorphone ER was well-tolerated, although 60 (13%) discontinued during the enrichment phase for adverse events and more active (9, 6.7%) than placebo (4, 3.0%) patients discontinued treatment for adverse events during the randomized phase.

CONCLUSIONS

These results provide evidence for the efficacy and safety of hydromorphone ER in opioid-tolerant patients with chronic moderate-to-severe LBP. Potential limitations include the shortened dose-conversion/titration phase, limiting the daily allowable dose of hydromorphone ER to 64 mg, and the allowance of limited rescue medication throughout the entire double-blind phase. Other trial design elements such as the use of an enrichment phase and the inclusion of only opioid tolerant patients may limit the generalizability of these results.

Authors+Show Affiliations

Gold Coast Research, LLC, Weston, FL 33331, USA. Goldcoast@POL.NETNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20429852

Citation

Hale, M, et al. "Once-daily OROS Hydromorphone ER Compared With Placebo in Opioid-tolerant Patients With Chronic Low Back Pain." Current Medical Research and Opinion, vol. 26, no. 6, 2010, pp. 1505-18.
Hale M, Khan A, Kutch M, et al. Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. Curr Med Res Opin. 2010;26(6):1505-18.
Hale, M., Khan, A., Kutch, M., & Li, S. (2010). Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. Current Medical Research and Opinion, 26(6), 1505-18. https://doi.org/10.1185/03007995.2010.484723
Hale M, et al. Once-daily OROS Hydromorphone ER Compared With Placebo in Opioid-tolerant Patients With Chronic Low Back Pain. Curr Med Res Opin. 2010;26(6):1505-18. PubMed PMID: 20429852.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. AU - Hale,M, AU - Khan,A, AU - Kutch,M, AU - Li,S, PY - 2010/5/1/entrez PY - 2010/5/1/pubmed PY - 2010/9/9/medline SP - 1505 EP - 18 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 26 IS - 6 N2 - OBJECTIVE: This multicenter, double-blind, placebo-controlled study using a randomized withdrawal design evaluated the efficacy and safety of once-daily OROS hydromorphone ER in the treatment of opioid-tolerant patients with chronic moderate-to-severe low back pain (LBP). MAIN OUTCOME MEASURES: The primary efficacy assessment was mean change in pain intensity based on patient diary Numeric Rating Scale (NRS) scores from baseline to final visit of the 12-week double-blind phase. Secondary endpoints included mean change from baseline to each visit in patient diary NRS scores; and office NRS scores; time to treatment failure; Patient Global Assessment; rescue medication use; and Roland Morris Disability Questionnaire total scores. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT00549042. RESULTS: For the primary outcome measure, hydromorphone ER significantly reduced pain intensity compared to placebo (p < 0.001). Median diary NRS score change from baseline to endpoint was significantly lower for OROS [corrected] hydromorphone ER (0.2 units) compared to placebo (1.6 units). [corrected] A significantly higher proportion of hydromorphone ER (60.6%) vs. placebo (42.9%) patients had at least a 30% reduction in diary NRS pain score from screening to endpoint (p < 0.01). Hydromorphone ER was well-tolerated, although 60 (13%) discontinued during the enrichment phase for adverse events and more active (9, 6.7%) than placebo (4, 3.0%) patients discontinued treatment for adverse events during the randomized phase. CONCLUSIONS: These results provide evidence for the efficacy and safety of hydromorphone ER in opioid-tolerant patients with chronic moderate-to-severe LBP. Potential limitations include the shortened dose-conversion/titration phase, limiting the daily allowable dose of hydromorphone ER to 64 mg, and the allowance of limited rescue medication throughout the entire double-blind phase. Other trial design elements such as the use of an enrichment phase and the inclusion of only opioid tolerant patients may limit the generalizability of these results. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/20429852/Once_daily_OROS_hydromorphone_ER_compared_with_placebo_in_opioid_tolerant_patients_with_chronic_low_back_pain_ L2 - https://www.tandfonline.com/doi/full/10.1185/03007995.2010.484723 DB - PRIME DP - Unbound Medicine ER -