CirrhosisNCT04509336
Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients
A study testing Orphenadrine and Baclofen in people with Cirrhosis, run by Mansoura University at 1 site in Egypt.
Trial summary
Muscle cramps are commonly affects patients with cirrhosis. It adversely influences the quality of life of cirrhotic patients. Treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.The effectiveness of baclofen and orphenadrine in controlling muscle cramps… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Orphenadrine and Baclofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2020to 20 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Cirrhotic patients complaining of frequent muscle cramps (>3 per week) for at least a month
Who cannot join
- Patients with allergy to study drugs
- Renal impairment
- Peripheral vascular disease
- Peripheral neuropathy
- Glaucoma
- Prostatic enlargement
Show all 10Show fewer
- Pregnancy and lactation
- Patients taking calcium channel blockers, and conjugated estrogens
- Patients taking vitamin E, taurine, carnitine, narcotic pain medications, muscle relaxants, nonsteroidal anti-inflammatory drugs, or antispastic agents during and for 2 weeks following the study
- Patients with alcoholic cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy and Safety of Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients
Muscle cramps are commonly affects patients with cirrhosis. It adversely influences the quality of life of cirrhotic patients. Treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.The effectiveness of baclofen and orphenadrine in controlling muscle cramps in cirrhotic patients has been presented in recent randomised controlled clinical trials;however, the comparative efficacy and safety between these two therapeutic options has not been previously investigated.
- Conditions
- Cirrhosis
- Being tested
- Orphenadrine, Baclofen
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrphenadrineDrug
100 mg twice daily
BaclofenDrug
initial dose of 10 mg tablet once daily, dose will be gradually increased according to the patients responses
| Study group | Role | What they receive |
|---|---|---|
| orphenadrine group | Experimental | orphenadrine Receives: Drug: Orphenadrine |
| Baclofen group | Active comparator | Baclofen Receives: Drug: Baclofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment
Questionnaire
Measured: 12 weeks
Secondary outcomes (1)
The difference in severity of cramps between orphenadrine and baclofen groups at the end of treatment
Visual analogue scale (VAS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start20 Aug 2020
- Primary completion1 Dec 2020
- Study completion20 Sep 2021
Why it stopped: COVID 19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
- Investigators
- Assem Elfert, Study chair, Tanta UniversitySherif Abd-Elsalam, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509336
- Sponsor's protocol ID
- 2020-87
- Status last verified
- Apr 2022
- First submitted
- 21 Jul 2020
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT04509336
- Acronym / sponsor ID
- 2020-87
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID 19 Pandemic
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Muscle cramps are commonly affects patients with cirrhosis. It adversely influences the quality of life of cirrhotic patients. Treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.The effectiveness of baclofen and orphenadrine in controlling muscle cramps in cirrhotic patients has been presented in recent randomised controlled clinical trials;however, the comparative efficacy and safety between these two therapeutic options has not been previously investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| orphenadrine group | Experimental | Drug: Orphenadrineorphenadrine |
| Baclofen group | Active comparator | Drug: BaclofenBaclofen |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-70 years
- Cirrhotic patients complaining of frequent muscle cramps (>3 per week) for at least a month
Key exclusion criteria (10 listed)
- Patients with allergy to study drugs
- Renal impairment
- Peripheral vascular disease
- Peripheral neuropathy
- Glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orphenadrine100 mg twice daily | Drug | orphenadrine group |
| Baclofeninitial dose of 10 mg tablet once daily, dose will be gradually increased according to the patients responses | Drug | Baclofen group |
Primary outcome
the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment
Time frame: 12 weeks
Questionnaire
1 secondary outcome
The difference in severity of cramps between orphenadrine and baclofen groups at the end of treatment
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: COVID 19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assem Elfert study chair
Tanta University
Sherif Abd-Elsalam principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orphenadrine and Baclofen in people with Cirrhosis, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID 19 Pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.