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Clinical study of the effect of oral administration of magnesium threoninate (L-TAMS) in morphine analgesia and tolerance

Clinical trial of the effect of oral administration of magnesium threoninate (L-TAMS) in morphine analgesia and tolerance

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN60931429
Enrollment
98
Registered
2018-01-24
Start date
2018-02-01
Completion date
Unknown
Last updated
2024-02-27

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

Conditions

Cancer pain Signs and Symptoms

Interventions

98 participants are randomly allocated to two groups. Those in group 1 (n = 49) are given magnesium threonate (L-TAMS) 1.5 g/day for 12 weeks. Those in group 2 (n = 49) are given placebo 1.5 g/day for

Sponsors

Xinhua Hospital (affiliated with Shanghai Jiaotong University School of Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects voluntarily signed the informed consent 2. Patients suffering from cancer pain with treatment of morphine, aged from 18 to 80 regardless of gender 3. Survival time is expected to exceed 3 months 4. Moderate to severe pain, VAS >4 points or more, or outbreak of pain >3 times/day 5. Patients can follow the drug dose and follow-up plan 6. Patients can describe the symptoms, no serious infection, respiratory insufficiency and has the ability to cooperate 7. Non-allergic persons 8. No drug abuse or drug addiction 9. Non-lactating, pregnant women. Subjects who did not have a pregnancy plan within 1 month after the test 10. Patients did not participate in a drug test within 3 months before this test (including the test drug)

Exclusion criteria

Exclusion criteria: 1. Researchers think that there is any reason they can't be included 2. In poor situation, severe systemic infection or respiratory dysfunction and uncooperative 3. Suffering from severe respiratory system, cardiovascular system diseases, liver and kidney dysfunction, cancer 4. Patients who are allergic to magnesium threonate (L-TAMS) 5. Patient who has a history of drug abuse 6. Breastfeeding, gestational women or subjects who do not have a pregnancy plan within 1 month after the test 7. Patients who participated in a drug trial within 3 months before this trial 8. Patients does not meet the inclusion criteria

Design outcomes

Primary

MeasureTime frame
1. Pain, measured using the visual analogue score (VAS) every day during the treatment. The frequency and intensity of the pain outbreak every day during the treatment 2. The dosage of morphine per day during the treatment

Secondary

MeasureTime frame
1. Intensity of anxiety, measured using the PHQ-9 evaluation scale every day during the treatment 2. Intensity of depression, measured by the GAD-7 anxiety screening scale) every day during the treatment 3. Quality of life, measured by the quality of life score (QOL) every day during the treatment

Countries

China

Outcome results

None listed

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