Using Orphenadrine to Treat Muscle Cramps in Patients with Cirrhosis
Randomized Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis
This study is testing if orphenadrine can help people with cirrhosis reduce their muscle cramps and improve their quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT02423395 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of orphenadrine, an anticholinergic medication, in alleviating muscle cramps experienced by patients with liver cirrhosis. Muscle cramps are a common and debilitating symptom in this population, and the study aims to determine if orphenadrine can improve their quality of life. Participants will be randomly assigned to receive either orphenadrine or a placebo, with the frequency and severity of muscle cramps being monitored throughout the trial. The study seeks to clarify the potential benefits of this medication in a population that has limited treatment options for muscle cramps.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with cirrhosis who experience muscle cramps at least three times per week.
Not a fit: Patients with renal impairment, certain vascular diseases, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from muscle cramps due to cirrhosis.
How similar studies have performed: While some small studies have explored treatments for muscle cramps in liver disease, this specific approach using orphenadrine is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cirrhosis * Muscle cramps( ≥3 cramps per week ) Exclusion Criteria: * • Allergy to orphenadrine * Renal impairment * Pregnant and lactating women * Peripheral vascular disease * Peripheral neuropathy * Medications as calcium channel blockers, conjugated estrogens and naproxen. Glaucoma Prostatic enlargement
Where this trial is running
Tanta
- Tanta university hospital — Tanta, Egypt (Recruiting)
Study contacts
- Principal investigator: Asem A Elfert, Professor — Tuh
- Study coordinator: Sherief M Abd-Elsalam, lecturer
- Email: Sherif_tropical@yahoo.com
- Phone: 01000058842
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.