Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00577967
Other study ID # 355/05
Secondary ID HARECCTR0500020
Status Not yet recruiting
Phase N/A
First received December 19, 2007
Last updated July 6, 2010
Start date October 2005
Est. completion date March 2006

Study information

Verified date July 2010
Source Hospital Authority, Hong Kong
Contact Yui Pong Siu, Dr
Phone (852) 2468 5750
Email maryvil@netivigator.com
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial Summary

To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Gabapentin


Locations

Country Name City State
China Tuen Mun Hospital Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
Hospital Authority, Hong Kong Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective measurement of reduction in pruritus 3 months
Secondary Tolerability of Gabapentin in CAPD patients 3 months
See also
  Status Clinical Trial Phase
Completed NCT05038982 - Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin Phase 2
Completed NCT04510090 - Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus Phase 1
Terminated NCT01825655 - Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching Phase 4
Completed NCT02143973 - Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus Phase 2/Phase 3
Completed NCT01236859 - Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus N/A
Completed NCT00782054 - Evaluation of Post Burn Rehabilitation Population for Itch Control Phase 4
Completed NCT04999787 - A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of HSK21542 Injection in Liver Disease Subjects With Pruritus Phase 2
Recruiting NCT04256759 - Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus Phase 2
Completed NCT04337073 - The Effect of Propofol on Dexamethasone-induced Perineal Pruritus Early Phase 1
Completed NCT04415034 - Scalp Pruritus Measurement Using Visual Analog Scale and 5-d Itch Scale in Children With Pediculosis Capitis
Active, not recruiting NCT05525520 - Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis Phase 2
Recruiting NCT03340155 - Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases N/A
Completed NCT04399525 - Influence of H1-antihistamines on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin. N/A
Recruiting NCT02432508 - Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis N/A
Completed NCT02653703 - L-menthol as a Topical Counter-irritant to TRPA1-induced Neurogenic Inflammation and Pain N/A
Completed NCT01963793 - Topical Aprepitant in Prurigo Patients Phase 2
Completed NCT01232985 - Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults Phase 2
Recruiting NCT06120907 - Swiss Itch Registry
Recruiting NCT04589429 - Adding Nalbuphine for Control of Intrathecal Morphine Pruritus Phase 2
Completed NCT03322137 - Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris Phase 2

External Links