Gabapentin as an Adjuvant Analgesic with Opioids for the Management of Metastatic Bone Pain

Gabapentin as an Adjuvant Analgesic with Opioids for the Management of Metastatic Bone Pain: Randomized, Double-Blind, Placebo-Controlled Crossover Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20140418002

Enrollment

Registered

2014-04-18

Start date

2013-09-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Metastatic Bone Pain Gabapentin&#44

Interventions

gabapentin (300 mg) at bed time on day 1&#44

bid on day 2 and q 8 hr. on day 3 through day 8 if the dose is well&#45

tolerated. Day 9 and 10 are tapering off days&#44

bid and OD respectively. Overall 24 days during the double&#45

blind treatment period.,placebo at bed time on day 1&#44

blind treatment period.

Active Comparator Drug,Placebo Comparator Drug

Gabapentin,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1 Age 8805 18 years 2 Malignant tumors with at least one metastatic bone lesion and bone pain is the major pain Bone metastasis is established by radiographic confirmation CT scan MRI nuclear scan 3 Numerical Rating Scale 8805 4 NRS from 0 to 10 in 24 hour period preceding the screening visit 4 Life expectancy 8805 30 days and Palliative Performance Scale PPS 8805 30 5 Regularly scheduled and stable dose of basal opioids medication for at least 24 hours Stable opioid use is defined as taking a constant daily dose of MSS 8804 3 dose day as rescue medication 6 No opioid related side effects 8804 Grade 2 of Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events CTCAE Version 4 0

Exclusion criteria

Exclusion criteria: 1 Hypersensitivity to gabapentin 2 Unable take oral medication 3 Creatinine clearance 60 mL min calculated by the Cockcroft Gault equation 4 Current gabapentin or pregabalin use within 5 days prior to screening 5 Pathologic fracture clinical or radiographic evidence of spinal cord compression or cauda equina syndrome 6 Chemotherapy from 2 weeks before screening throughout the study 7 Radiotherapy to the pain producing lesion from 1 month before screening throughout the study 8 New hormone therapy or increase the dose during the study 9 New bisphosphonate therapy over the course of study

Design outcomes

Primary

Measure	Time frame
average absolute pain intensity difference day 1 and day 8 of each period Numerical rating scale	—

Secondary

Measure	Time frame
Incidence of side effect Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	—

Countries

Thailand

Contacts

Public ContactJatuporn Thonsontia

Maharat Nakhon Ratchasima Hospital

Jatu_air@yahoo.com0819760169

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026