Uremic PruritusPhase 4NCT03758079
Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus
A Phase 4 study testing Doxepin and Gabapentin in people with Uremic Pruritus, run by University of Balamand at 1 site in Lebanon.
Trial summary
This is a single blind randomized trial to compare efficacy and side effects of Gabapentin with Doxepin. Hemodialysis patients with uremic pruritus at one dialysis center of Saint George Hospital University Medical Centre were included in this study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- Doxepin and Gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jun 2018to 8 Oct 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prevalent patients undergoing HD with UP for at least three months
- any medications with antipruritic effects to be discontinued one week before the study
- Hemodialysis performed for 3-4 h thrice weekly via a low flux polysulphonedialyser [1.3-1.6 m2 surface areas] using bicarbonate and/or acetate dialysis fluid
- well controlled Calcium, Phosphorus and iPTH levels
Who cannot join
- patients labeled high risk of fall (Having a score more than 16/20 using part 1 from Falls Risk Assessment Tool (FRAT)
- patients taking drugs that interact with doxepin or gabapentin
- patients with hepatic failure
- patients with hyperthyroidism
- patients with narrow angle glaucoma
- patients with heart block or decompensated heart failure or hypotension (defined as systolic blood pressure less than 90 mmHg) or myocardial infarction in the past three months
Show all 10Show fewer
- history of allergy to gabapentin or doxepin
- uncontrolled psychiatric diseases
- pregnant patients
- patients with psoriasis, atopic dermatitis or any other condition that can justify the pruritus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus: Pilot Study
This is a single blind randomized trial to compare efficacy and side effects of Gabapentin with Doxepin. Hemodialysis patients with uremic pruritus at one dialysis center of Saint George Hospital University Medical Centre were included in this study. Patients were divided into 2 groups to receive either 10 mg Doxepin daily or Gabapentin at a dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks, after which patients were treated reversley. Pruritus severity and its effect on quality of life will be assessed by using visual analog scale (VAS), 5-D pruritus scale and dermatology life quality index (DLQI). Include patients will have to fill these forms at baseline and at end of week1, week2 and week4
Read the detailed description
Pruritus is one of the frustrating skin manifestations of advanced renal failure. Many options have been used for the management of uremic pruritus (UP) such as Pregabalin, Gabapentin, Doxepine and Desloratidine. Gabapentin, a GABAergic drug, has been found to be effective in the treatment of uremic pruritus. Doxepin, a potent antihistamine drug, is used orally or topically in many pruritic conditions such as UP, idiopathic pruritus, atopic dermatitis, neurogenic, or psychogenic pruritus and, in the management of the UP in hemodialysis patients.
No comparative head to head study between Gabapentin and Doxepine has been conducted to date. The aim of this study was to compare Gabapentin and Doxepin in treatment of uremic pruritus in hemodialysis patients.
- Conditions
- Uremic Pruritus
- Being tested
- Doxepin, Gabapentin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxepinDrug
Also called Silenor, Sinequan, Adapin
10 mg Doxepin for 4 weeks
GabapentinDrug
Also called Neurontin, Gralise, Gabarone, Fanatrex
dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Doxepin | Active comparator | 10 mg Doxepin daily for 4 weeks Receives: Drug: Doxepin |
| Gabapentin | Active comparator | Gabapentin 100mg after each dialysis session Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Worst-itching Visual Analog Scale (VAS) at week 4
a 10cm horizontal line marked from zero (no pruritus) to 10 (worst possible pruritus). The pruritus will be assessed subjectively and scored as follows: no pruritus (VAS score 0), mild (VAS score 1-3) with episodic and localized pruritus without disturbance in usual work and sleep, moderate (VAS score 4-7) with generalized and continuous pruritus without sleep disturbance and severe (VAS score 8-10) with generalized, continuous pruritus and sleep disturbance.
Measured: 1, 2, 4 weeks
Change from baseline in 5-D Itch Scale score at week 4
multidimensional questionnaire. The five dimensions are degree, duration, direction, disability and distribution. The scores of each of the five domains will be achieved separately and then summed together to obtain a total 5-D score ranging between five (no pruritus) and 25 (most severe pruritus). For the distribution domain, the number of affected body parts is tallied (potential sum 0-16) and the sum is sorted into five scoring bins: sum of 0-21⁄4score of 1, sum of 3-51⁄4score of 2, sum of 6-101⁄4score of 3, sum of 11-131⁄4score of 4 and sum of 14-161⁄4score of 5
Measured: 1, 2, 4 weeks
Change from baseline in Dermatology life quality index (DLQI) at week 4
10-Item questionnaire evaluating: impact of skin condition on HRQoL during the past week, symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment. A Score range from 0 to 30.
Measured: 1, 2, 4 weeks
Secondary outcomes (1)
side effects of each treatment
Number of patients who report side effects while on each treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Jun 2018
- Primary completion8 Oct 2018
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uremic 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Balamand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julien Bachour, MD, University of Balamand
- Investigators
- Roger N Haber, MD, Principal investigator, University of Balamand/Saint George Hospital University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758079
- Sponsor's protocol ID
- 064-17/717
- Status last verified
- Nov 2018
- First submitted
- 19 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus: Pilot Study
- ClinicalTrials.gov ID
- NCT03758079
- Acronym / sponsor ID
- 064-17/717
- Conditions
- Uremic Pruritus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of BalamandUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 29 Nov 2018 (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.
This is a single blind randomized trial to compare efficacy and side effects of Gabapentin with Doxepin. Hemodialysis patients with uremic pruritus at one dialysis center of Saint George Hospital University Medical Centre were included in this study. Patients were divided into 2 groups to receive either 10 mg Doxepin daily or Gabapentin at a dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks, after which patients were treated reversley. Pruritus severity and its effect on quality of life will be assessed by using visual analog scale (VAS), 5-D pruritus scale and dermatology life quality index (DLQI). Include patients will have to fill these forms at baseline and at end of week1, week2 and week4
Detailed description
Pruritus is one of the frustrating skin manifestations of advanced renal failure. Many options have been used for the management of uremic pruritus (UP) such as Pregabalin, Gabapentin, Doxepine and Desloratidine. Gabapentin, a GABAergic drug, has been found to be effective in the treatment of uremic pruritus. Doxepin, a potent antihistamine drug, is used orally or topically in many pruritic conditions such as UP, idiopathic pruritus, atopic dermatitis, neurogenic, or psychogenic pruritus and, in the management of the UP in hemodialysis patients.
No comparative head to head study between Gabapentin and Doxepine has been conducted to date. The aim of this study was to compare Gabapentin and Doxepin in treatment of uremic pruritus in hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxepin | Active comparator | Drug: Doxepin10 mg Doxepin daily for 4 weeks |
| Gabapentin | Active comparator | Drug: GabapentinGabapentin 100mg after each dialysis session |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- prevalent patients undergoing HD with UP for at least three months
- any medications with antipruritic effects to be discontinued one week before the study
- Hemodialysis performed for 3-4 h thrice weekly via a low flux polysulphonedialyser [1.3-1.6 m2 surface areas] using bicarbonate and/or acetate dialysis fluid
- well controlled Calcium, Phosphorus and iPTH levels
Key exclusion criteria (10 listed)
- patients labeled high risk of fall (Having a score more than 16/20 using part 1 from Falls Risk Assessment Tool (FRAT)
- patients taking drugs that interact with doxepin or gabapentin
- patients with hepatic failure
- patients with hyperthyroidism
- patients with narrow angle 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 |
|---|---|---|
| DoxepinAlso: Silenor, Sinequan, Adapin10 mg Doxepin for 4 weeks | Drug | Doxepin |
| GabapentinAlso: Neurontin, Gralise, Gabarone, Fanatrexdose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks | Drug | Gabapentin |
Primary outcome
Change from baseline in Worst-itching Visual Analog Scale (VAS) at week 4
Time frame: 1, 2, 4 weeks
a 10cm horizontal line marked from zero (no pruritus) to 10 (worst possible pruritus). The pruritus will be assessed subjectively and scored as follows: no pruritus (VAS score 0), mild (VAS score 1-3) with episodic and localized pruritus without disturbance in usual work and sleep, moderate (VAS score 4-7) with generalized and continuous pruritus without sleep disturbance and severe (VAS score 8-10) with generalized, continuous pruritus and sleep disturbance.
Change from baseline in 5-D Itch Scale score at week 4
Time frame: 1, 2, 4 weeks
multidimensional questionnaire. The five dimensions are degree, duration, direction, disability and distribution. The scores of each of the five domains will be achieved separately and then summed together to obtain a total 5-D score ranging between five (no pruritus) and 25 (most severe pruritus). For the distribution domain, the number of affected body parts is tallied (potential sum 0-16) and the sum is sorted into five scoring bins: sum of 0-21⁄4score of 1, sum of 3-51⁄4score of 2, sum of 6-101⁄4score of 3, sum of 11-131⁄4score of 4 and sum of 14-161⁄4score of 5
Change from baseline in Dermatology life quality index (DLQI) at week 4
Time frame: 1, 2, 4 weeks
10-Item questionnaire evaluating: impact of skin condition on HRQoL during the past week, symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment. A Score range from 0 to 30.
1 secondary outcome
side effects of each treatment
Time frame: 4 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 29 Nov 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Uremic Pruritus
Active, not recruitingObservational study
Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
End-Stage Kidney Disease (ESKD), Hemodialysis
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.
Roger N Haber, MD principal investigator
University of Balamand/Saint George Hospital University Medical Center
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 Doxepin and Gabapentin in people with Uremic Pruritus, run by University of Balamand at 1 site in Lebanon.
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 4 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: finished, as of the sponsor's last update on 29 Nov 2018. 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 Lebanon. 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?
Change from baseline in Worst-itching Visual Analog Scale (VAS) at week 4 (time frame: 1, 2, 4 weeks). The study lists 3 primary outcomes in all. 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 Nov 2018.