PruritusNCT00577967
Gabapentin - A Solution to Uremic Pruritus?
A study testing Gabapentin in people with Pruritus and Uremia, run by Hospital Authority, Hong Kong at 1 site in China.
Trial summary
To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Gabapentin
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Oct 2005to Mar 2006
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Adult Chinese male and female patients aged > 18 undergoing CAPD for at least 3 months and able to read and understand Chinese
- Patients experiencing moderate to severe pruritis, defined as persistent, treatment-resistant pruritis considerably impairing sleep or daytime activity. Treatment resistance is defined as no or only partial resolvement of pruritis under current anti-pruritis treatment regimens such as anti-pruritis lotions and anti-histamines.
- Patients in stable clinical condition in terms of peritoneal dialysis and general health
- Patients able to understand and answer the SDS questionnaire
- Patients able to express the sensation of itchiness in the terms of the VAS and the SDS score
- Patients who are willing to give written informed consent and to participate in and comply with the study protocol
Who cannot join
- Patients with a known history of pruritis or dermatologic disease antedating renal failure.
- Patients with skin disease other than the usual cutaneous findings of uraemia such as xerosis or ecchymosis.
- Patients under current treatment with systemic steroids
- Known history of allergy to Gabapentin
- Those patients already put on anti-convulsants
- Unable to give written informed consent for the study
Show all 11Show fewer
- Pregnancy or female patients of child-bearing age who are unwilling to use contraception
- Poor drug compliance
- Known HIV positivity
- Active neoplastic disease
- Those who do not want to participate the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study
To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis.
- Being tested
- Gabapentin
- Keywords
- Uremic pruritis
- Medical subject headings
- Pruritus, Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective measurement of reduction in pruritus
Measured: 3 months
Secondary outcomes (1)
Tolerability of Gabapentin in CAPD patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startOct 2005
- Study completionMar 2006 (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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Pfizer
- Investigators
- Yui Pong Siu, Dr, Principal investigator, Medical and Geriatrics / Nephrology, Tuen Mun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577967
- Sponsor's protocol ID
- 355/05
- Other IDs
- HARECCTR0500020
- Status last verified
- Jul 2010
- First submitted
- 19 Dec 2007
- Last updated
- 7 Jul 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 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study
- ClinicalTrials.gov ID
- NCT00577967
- Acronym / sponsor ID
- 355/05
- Keywords
- Uremic pruritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Pfizer
- Study start
- Oct 2005
- Study completion
- Mar 2006 (estimated)
- First posted
- 20 Dec 2007 (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.
To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Adult Chinese male and female patients aged > 18 undergoing CAPD for at least 3 months and able to read and understand Chinese
- Patients experiencing moderate to severe pruritis, defined as persistent, treatment-resistant pruritis considerably impairing sleep or daytime activity. Treatment resistance is defined as no or only partial resolvement of pruritis under current anti-pruritis treatment regimens such as anti-pruritis lotions and anti-histamines.
- Patients in stable clinical condition in terms of peritoneal dialysis and general health
- Patients able to understand and answer the SDS questionnaire
- Patients able to express the sensation of itchiness in the terms of the VAS and the SDS score
Key exclusion criteria (11 listed)
- Patients with a known history of pruritis or dermatologic disease antedating renal failure.
- Patients with skin disease other than the usual cutaneous findings of uraemia such as xerosis or ecchymosis.
- Patients under current treatment with systemic steroids
- Known history of allergy to Gabapentin
- Those patients already put on anti-convulsants
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 |
|---|---|---|
| Gabapentin | Drug | – |
Primary outcome
Subjective measurement of reduction in pruritus
Time frame: 3 months
1 secondary outcome
Tolerability of Gabapentin in CAPD patients
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 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.
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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.
Yui Pong Siu, Dr principal investigator
Medical and Geriatrics / Nephrology, Tuen Mun Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin in people with Pruritus and Uremia, run by Hospital Authority, Hong Kong at 1 site in China.
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 6 inclusion and 11 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 7 Jul 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yui Pong Siu, Dr ((852) 2468 5750, maryvil@netivigator.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective measurement of reduction in pruritus (time frame: 3 months). 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 NCT00577967, 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 7 Jul 2010.