PruritusPhase 4NCT05750875
Gabapentin Versus Loratadine in Uremic Pruritus
A Phase 4 study testing Loratadine and Gabapentin in people with Pruritus and Uremia, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the efficacy of gabapentin with loratadine in reducing the severity of uremic pruritus in patients of chronic kidney disease and to compare the side effects of both drugs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pruritus, Uremia, Chronic Kidney Diseases
- What is being tested?
- Loratadine and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2022to 31 Oct 2022
- Phase
- Phase 4
- 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
- Chronic kidney disease, stage 3 and above, irrespective of dialysis status
- Persistent pruritus, of moderate to very severe intensity (≥ 4 points on numerical rating scale), occurring at least 3 times a week, for at least 2 weeks, in a 1-month period.
Who cannot join
- Chronic skin conditions such as eczema, psoriasis, etc.
- Pruritus due to any other cause, such as metabolic abnormalities, liver disease, etc.
- History of drugs causing pruritus such as opioids, etc
- Pregnant patients
- Preceding history of allergy to either gabapentin or loratadine.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
King Edward Medical University/Mayo Hospital
Lahore, Punjab Province, 54000
About this study
Official title: Comparison of the Efficacy of Gabapentin With Loratadine in the Treatment of Uremic Pruritus in Patients of Chronic Kidney Disease
The goal of this clinical trial is to compare the efficacy of gabapentin with loratadine in reducing the severity of uremic pruritus in patients of chronic kidney disease and to compare the side effects of both drugs. The main questions it aims to answer are:
- Which drug (gabapentin versus loratadine) is more effective in reducing the severity of uremic pruritus?
- Which drug (gabapentin versus loratadine) has fewer side effects?
Read more
Participants were divided into two groups.Group A received loratadine 10mg daily and group B received gabapentin 100mg daily. Both groups were given treatment for 4 weeks.
- Participants were asked to grade the severity of pruritus on a numerical rating scale and also answer the Dermatology Life Quality Index Questionnaire (DLQI)
- Participants were also asked to report any side effects, if occurred.
Researchers compared both groups with regards to improvement in pruritus severity, DLQI score and side effects.
Read the detailed description
Informed written consent was taken from all the participants. Participants were asked to discontinue any topical or systemic antipruritic drugs, for least 1 week prior to the study. Demographic, clinical and laboratory data (complete blood count, renal function tests, liver function tests, serum electrolytes and ultrasound abdomen) was evaluated at baseline. Glomerular Filtration Rate (GFR) and stage of chronic kidney disease was calculated. Participants were randomly allocated to two groups. One group received loratadine 10mg daily and the other received gabapentin 100mg daily. Those participants undergoing hemodialysis received their respective dose after the dialysis session. Both groups were given treatment for 4 weeks. Participants were asked to grade the severity of pruritus on a numerical rating scale and also answer the Dermatology Life Quality Index Questionnaire.These proformas were filled once at the start of the study, at 2 weeks and then at the end of study i.e. 4 weeks. Participants were also asked to report any adverse events, if occurred.
The Statistical Package for the Social Sciences (SPSS) version 25.0 was used to analyze the data. Qualitative data (like gender, dialysis status, etc.) was expressed in the form of frequency and percentages while quantitative data (like age, weight, serum creatinine levels, etc.) was represented as mean and standard deviations (Mean±SD). The reduction in scores of numerical rating scale and Dermatology Life Quality Index Questionnaire was calculated from baseline. Mean reduction in scores were compared between the two groups and independent sample t-test was applied. p-value <0.05 was considered as significant.
- Conditions
- Pruritus, Uremia, Chronic Kidney Diseases
- Being tested
- Loratadine, Gabapentin
- Keywords
- Efficacy, Gabapentin, Loratadine, Uremic Pruritus
- Medical subject headings
- Pruritus, Uremia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoratadineDrug
Participants were given loratadine 10mg, oral, daily, for 4 weeks
GabapentinDrug
Participants were given gabapentin 100mg, oral, daily, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Loratadine | Active comparator | Not described Receives: Drug: Loratadine |
| Gabapentin | Active comparator | Not described Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean reduction in pruritus score, from baseline till 4 weeks, as measured on a numerical rating scale.
Reduction in pruritus score as measured on a numerical rating scale, numbered between '0' (corresponding to no itch) and '10' (the worst imaginable itch).
Measured: Four weeks
Secondary outcomes (2)
Mean reduction in Dermatology Life Quality Index Questionnaire score, from baseline till 4 weeks.
Dermatology Life Quality Index Questionnaire score ranging from from 0 (no impairment of life quality) to 30 (maximum impairment).
Measured: Four weeks
Comparison of side effects of gabapentin and loratadine, as reported by the participants.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 May 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fawad Ahmad Randhawa, King Edward Medical University
- Investigators
- Noor-Un-Nisaa Zia, MD Medicine, Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750875
- Sponsor's protocol ID
- 9669/REG/KEMU/2021
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 16 Mar 2023
- 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 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Gabapentin With Loratadine in the Treatment of Uremic Pruritus in Patients of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05750875
- Acronym / sponsor ID
- 9669/REG/KEMU/2021
- Conditions
- Pruritus, Uremia, Chronic Kidney Diseases
- Keywords
- Efficacy, Gabapentin, Loratadine, Uremic Pruritus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 2 Mar 2023 (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.
The goal of this clinical trial is to compare the efficacy of gabapentin with loratadine in reducing the severity of uremic pruritus in patients of chronic kidney disease and to compare the side effects of both drugs. The main questions it aims to answer are:
- Which drug (gabapentin versus loratadine) is more effective in reducing the severity of uremic pruritus?
- Which drug (gabapentin versus loratadine) has fewer side effects?
Participants were divided into two groups.Group A received loratadine 10mg daily and group B received gabapentin 100mg daily. Both groups were given treatment for 4 weeks.
- Participants were asked to grade the severity of pruritus on a numerical rating scale and also answer the Dermatology Life Quality Index Questionnaire (DLQI)
- Participants were also asked to report any side effects, if occurred.
Researchers compared both groups with regards to improvement in pruritus severity, DLQI score and side effects.
Detailed description
Informed written consent was taken from all the participants. Participants were asked to discontinue any topical or systemic antipruritic drugs, for least 1 week prior to the study. Demographic, clinical and laboratory data (complete blood count, renal function tests, liver function tests, serum electrolytes and ultrasound abdomen) was evaluated at baseline. Glomerular Filtration Rate (GFR) and stage of chronic kidney disease was calculated. Participants were randomly allocated to two groups. One group received loratadine 10mg daily and the other received gabapentin 100mg daily. Those participants undergoing hemodialysis received their respective dose after the dialysis session. Both groups were given treatment for 4 weeks. Participants were asked to grade the severity of pruritus on a numerical rating scale and also answer the Dermatology Life Quality Index Questionnaire.These proformas were filled once at the start of the study, at 2 weeks and then at the end of study i.e. 4 weeks. Participants were also asked to report any adverse events, if occurred.
The Statistical Package for the Social Sciences (SPSS) version 25.0 was used to analyze the data. Qualitative data (like gender, dialysis status, etc.) was expressed in the form of frequency and percentages while quantitative data (like age, weight, serum creatinine levels, etc.) was represented as mean and standard deviations (Mean±SD). The reduction in scores of numerical rating scale and Dermatology Life Quality Index Questionnaire was calculated from baseline. Mean reduction in scores were compared between the two groups and independent sample t-test was applied. p-value <0.05 was considered as significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loratadine | Active comparator | Drug: Loratadine |
| Gabapentin | Active comparator | Drug: Gabapentin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic kidney disease, stage 3 and above, irrespective of dialysis status
- Persistent pruritus, of moderate to very severe intensity (≥ 4 points on numerical rating scale), occurring at least 3 times a week, for at least 2 weeks, in a 1-month period.
Key exclusion criteria (5 listed)
- Chronic skin conditions such as eczema, psoriasis, etc.
- Pruritus due to any other cause, such as metabolic abnormalities, liver disease, etc.
- History of drugs causing pruritus such as opioids, etc
- Pregnant patients
- Preceding history of allergy to either gabapentin or loratadine.
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 |
|---|---|---|
| LoratadineParticipants were given loratadine 10mg, oral, daily, for 4 weeks | Drug | Loratadine |
| GabapentinParticipants were given gabapentin 100mg, oral, daily, for 4 weeks | Drug | Gabapentin |
Primary outcome
Mean reduction in pruritus score, from baseline till 4 weeks, as measured on a numerical rating scale.
Time frame: Four weeks
Reduction in pruritus score as measured on a numerical rating scale, numbered between '0' (corresponding to no itch) and '10' (the worst imaginable itch).
2 secondary outcomes
Mean reduction in Dermatology Life Quality Index Questionnaire score, from baseline till 4 weeks.
Time frame: Four weeks
Comparison of side effects of gabapentin and loratadine, as reported by the participants.
Time frame: Four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- 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.
Noor-Un-Nisaa Zia, MD Medicine principal investigator
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Loratadine and Gabapentin in people with Pruritus and Uremia, run by King Edward Medical University at 1 site in Pakistan.
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 5 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: finished, as of the sponsor's last update on 16 Mar 2023. 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean reduction in pruritus score, from baseline till 4 weeks, as measured on a numerical rating scale. (time frame: Four 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 16 Mar 2023.