Uremic PruritusPhase 4NCT01073501
Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus
A Phase 4 study testing Pregabalin in people with Uremic Pruritus, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced or end-stage renal disease. Its intensity ranges from sporadic discomfort to complete restlessness during both the day- and night-time and its distribution varies significantly over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Mar 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of pruritus of >8 weeks duration.
- Severity of pruritus of 7 or more defined by visual analogue scale.
- No improvement by oral antihistamines or skin moisturizers.
- Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study.
- Negative pregnancy test result for all participating women of childbearing age;
Who cannot join
- Known allergy to Pregabalin
- Any acute illness;
- Liver cirrhosis
- Active dermatological disorder other than UP
- Decompensated heart failure;
- Inability to give informed consent;
- Poor compliance.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shaare Zedek Medical Center
Jerusalem, 91031
LINDA SHAVIT, MD, 97226555086, lshavit@szmc.org.il
linda shavit, MD
About this study
Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced or end-stage renal disease. Its intensity ranges from sporadic discomfort to complete restlessness during both the day- and night-time and its distribution varies significantly over time. Many attempts have been made to relieve this bothersome symptom in affected patients, however with generally limited success. Incidence of UP varies widely between studies and seems to decline over the last 30 years (from 85% in the 1970s and 50-60% in the 1980s to a 22% in the 2000s) (Gunal AI).
We use Pregabalin for the relief of diabetic neuropathic pain in patients on haemodialysis in our centre. In addition to neuropathic pain, several of our patients have complained of pruritus and after Pregabalin treatment, their pruritus has promptly and completely resolved. Accordingly, we intend to conduct a double-blind, placebo-controlled, crossover trial to assess the effectiveness of Pregabalin in chronic UP.
- Conditions
- Uremic Pruritus
- Being tested
- Pregabalin, Placebo
- Keywords
- UREMIC PRURITUS, PREGABALIN, UP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Pregabalin 25 mg (Lyrica; Pfizer, Germany) or placebo will be administered orally daily at the end of hemodialysis sessions in dialysis patients or every evening in non dialysis CKD patients. The dose will be increased up to 50 mg if no improvement of pruritus will be established at the end of first week of the study
PlaceboDrug
Pregabalin 25 mg (Lyrica; Pfizer, Germany) or placebo will be administered orally daily at the end of hemodialysis sessions in dialysis patients or every evening in non dialysis CKD patients. The dose will be increased up to 50 mg if no improvement of pruritus will be established at the end of first week of the study
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo versus pregabalin Receives: Drug: Placebo |
| Pregabalin | Experimental | Placebo versus pregabalin Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of UP by more than 50% after Pregabalin administration
Measured: 2012
Secondary outcomes (1)
Reduction of chronic pain of various origin and improvement in insomnia after Pregabalin administration
Measured: 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073501
- Sponsor's protocol ID
- 111.CT.IL
- Status last verified
- Feb 2010
- First submitted
- 17 Feb 2010
- Last updated
- 23 Feb 2010
- Results posted
- No
Publications
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
PubMed 33283264
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus
- ClinicalTrials.gov ID
- NCT01073501
- Acronym / sponsor ID
- 111.CT.IL
- Conditions
- Uremic Pruritus
- Keywords
- UREMIC PRURITUS, PREGABALIN, UP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 23 Feb 2010 (estimated)
- 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.
Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced or end-stage renal disease. Its intensity ranges from sporadic discomfort to complete restlessness during both the day- and night-time and its distribution varies significantly over time. Many attempts have been made to relieve this bothersome symptom in affected patients, however with generally limited success. Incidence of UP varies widely between studies and seems to decline over the last 30 years (from 85% in the 1970s and 50-60% in the 1980s to a 22% in the 2000s) (Gunal AI).
We use Pregabalin for the relief of diabetic neuropathic pain in patients on haemodialysis in our centre. In addition to neuropathic pain, several of our patients have complained of pruritus and after Pregabalin treatment, their pruritus has promptly and completely resolved. Accordingly, we intend to conduct a double-blind, placebo-controlled, crossover trial to assess the effectiveness of Pregabalin in chronic UP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo versus pregabalin |
| Pregabalin | Experimental | Drug: PregabalinPlacebo versus pregabalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of pruritus of >8 weeks duration.
- Severity of pruritus of 7 or more defined by visual analogue scale.
- No improvement by oral antihistamines or skin moisturizers.
- Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study.
- Negative pregnancy test result for all participating women of childbearing age;
Key exclusion criteria (7 listed)
- Known allergy to Pregabalin
- Any acute illness;
- Liver cirrhosis
- Active dermatological disorder other than UP
- Decompensated heart failure;
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 |
|---|---|---|
| PregabalinPregabalin 25 mg (Lyrica; Pfizer, Germany) or placebo will be administered orally daily at the end of hemodialysis sessions in dialysis patients or every evening in non dialysis CKD patients. The dose will be increased up to 50 mg if no improvement of pruritus will be established at the end of first week of the study | Drug | Pregabalin |
| PlaceboPregabalin 25 mg (Lyrica; Pfizer, Germany) or placebo will be administered orally daily at the end of hemodialysis sessions in dialysis patients or every evening in non dialysis CKD patients. The dose will be increased up to 50 mg if no improvement of pruritus will be established at the end of first week of the study | Drug | Placebo |
Primary outcome
Reduction of UP by more than 50% after Pregabalin administration
Time frame: 2012
1 secondary outcome
Reduction of chronic pain of various origin and improvement in insomnia after Pregabalin administration
Time frame: 2012
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2010.
- Derived from this study: PubMed 33283264Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
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.
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 Pregabalin in people with Uremic Pruritus, run by Shaare Zedek Medical Center at 1 site in Israel.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Feb 2010. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LINDA SHAVIT, MD (97226555086, lshavit@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of UP by more than 50% after Pregabalin administration (time frame: 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01073501, which also lists 1 linked publication.
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 23 Feb 2010.