A Phase 3 interventional study of orphenadrine and Placebo in Liver Cirrhosis and Muscle Cramps, sponsored by Sherief Abd-Elsalam. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2019-06-07.
Sponsored by Sherief Abd-Elsalam · Phase 3, Interventional, and Treatment
Among 54 studies in Liver Cirrhosis with a site in Egypt — 10 open to participants now, 11 under way, 2 of them phase 3. Liver Cirrhosis · Egypt.
Among the 54 studies in Liver Cirrhosis with a site in Egypt, this one is the 9th largest by planned enrollment of the 24 interventional ones, is one of 2 that started in 2015, is one of 8 in phase 3, reaches primary completion later than 10 of the 10 other live ones, and was the 5th registered.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 100 is above the median of 78 across 739 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →10 of the 54 studies in Liver Cirrhosis with a site in Egypt are open now, in 1 country. Each count lists the studies.
Of the 208 Liver Cirrhosis studies recruiting now, 101 (49%) set no upper age limit and 66 (32%) stop at 75 or younger; 12 take children under 18; 25 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →54 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 2 started in 2015.
Median enrollment 100 across the 24 interventional studies, 100 across the 30 observational. Of the 28 that completed or were terminated, 1 (4%) have results posted.
1 of 54 have an industry lead sponsor. The 10 most frequent:
Sherief Abd-Elsalam is the lead sponsor of 50 studies on the registry; 23 are open to participants now.
Sherief Abd-Elsalam has 5 studies filed under Liver Cirrhosis — fewer than ten, so there is no comparison to draw.
1 of the studies in Liver Cirrhosis with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07513922Assiut UniversityThe Correlation Between hs CRP TG Triglycerides Glucose Index in NAFLD and Liver Fibrosis | 2027-10-02 |
Among the 54 studies in Liver Cirrhosis with a site in Egypt, from their registry updates:
Nothing recorded among them since 2026-09-25.
Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4]
Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes [1].
Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking [2].
Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4] Orphenadrine is structurally related to diphenhydramine and carries relatively stronger anticholinergic and weaker sedative properties, It is mostly excreted through the kidneys.[5]
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Allergy to orphenadrine
50 patients will be treated with orphenadrine 100 mg twice daily for 1 month
Drug: orphenadrine
50 patients will be given placebo
Drug: Placebo
Orphenadrine in muscle cramps in cirrhotic patients
Also known as: Norflex
calcium in muscle cramps in cirrhotic patients
Also known as: calcium
Frequency of muscle cramps
questionnaire
Time frame: 3 months
Quality of life of these patients
questionnaire
Time frame: 3 months
Plan to share: No
The record gives a start of Jan 2015, a primary completion of Dec 2028 and a completion of Dec 2028. It does not say whether these dates are actual or estimated.
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Studies of the drug tested here: Orphenadrine
Sherief Abd-Elsalam