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Efficient Assessment of Pregabalin Combined With Morphine Using in Patients With Neuropathic Cancer Pain

Clinical Research of Pregabalin in the Treatment of Moderate to Severe Cancer Pain

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-13003121
Enrollment
Unknown
Registered
2013-02-23
Start date
2013-06-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer pain

Interventions

Group ?:morphine-pregabalin combination followed by morphine-placebo
Group ?:morphine-placebo combination followed by morphine-pregabalin

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with cancer pain whose pain intensity>=4 on a 0 to 10 numerical rating scale (NRS) before analgesia treatment; pain intensity could be controlled with morphine monotherapy at a range of 0 to 3 and breakthrough pain=180mg/day; neuropathic pain diagnosis according to Douleur Neuropathique 4 questionnaire (DN4) (on a scale from 0 to 10, with higher number indicating probability of neuropathic pain), DN4>= 4[17]. In order to make sure that patients were at a stable stage of cancer during the study, their Kamofsky performance status (KPS) (on a scale from 0 to 100, with higher numbers indicating ability of living independence) must be >=40 and quality of life (QOL) (on a scale from 0 to 60, with higher numbers indicating better health-related quality of life)>30.

Exclusion criteria

Exclusion criteria: Patients who were unable to take medications orally, currently receiving oncologic treatment, unable to cooperate, plasma creatinine>1.5 mg/ml or creatinine clearance<60 ml/min, taking nonopioid analgesics and other adjuvant drugs also were excluded from the study. Patients were withdrawn from the study when a new pain due to disease progression developed or when intolerable side effects occurred during the study.

Design outcomes

Primary

MeasureTime frame
Numeric rating scale;Medical outcomes study sleep scale;

Secondary

MeasureTime frame
Constipation assessment scale;Hamilton Anxiety Scale;Hamilton Depression Scale;

Countries

China

Contacts

Public ContactDou Zhi
douzhisparks@gmail.com+86 14795591007

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026