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Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Poitiers University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01061073
First received: January 29, 2010
Last updated: March 2, 2010
Last verified: March 2010
History of Changes
  Purpose

JJ ureteral stent represents an advance in the management of the upper urinary tract obstruction as it allows the patient to resume his activities although he is stented between the kidney and the bladder.

However, in many cases, this JJ stent is not well tolerated and can even be unbearable.

This trial evaluates the benefit of tamsulosin (an alpha-blocker) in improving the tolerance of JJ stents compared to low-doses of phloroglucinol.


Condition Intervention Phase
Non-oncological Indication to Ureteral Stenting
 Drug: Omexel
Drug: spasfon
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:
  • Evaluate the benefit of alpha-blockers (Tamsulosin, group A) compared to phloroglucinol (Spasfon®, group B) as regards patients tolerance to JJ stents [ Time Frame: 1 month treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of complications [ Time Frame: after 1 month treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: February 2010
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omexel Drug: Omexel
Active Comparator: spasfon Drug: spasfon

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 18 or more.
  2. Non-oncological indication to ureteral stenting
  3. Informed written consent

Exclusion Criteria:

1 Any contra-indication to Tamsulosin or phloroglucinol (renal or hepatic insufficiency, allergy) 2. Pregnancy 3. Patients already treated with alpha blockers

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061073

Contacts
Contact: Jacques IRANI, MD 0549444475 j.irani@chu-poitiers.fr

Locations
France
Poitiers University Hospital - 2 rue de la Milétrie Recruiting
Poitiers, France, 86021
Contact: Jacques IRANI, MD     05 49 44 44 75     j.irani@chu-poitiers.fr    
Sponsors and Collaborators
Poitiers University Hospital
  More Information

No publications provided

Responsible Party: Pr IRANI - principal investigator, CHU DE POITIERS
ClinicalTrials.gov Identifier: NCT01061073     History of Changes
Other Study ID Numbers: JJ Alpha 2009
Study First Received: January 29, 2010
Last Updated: March 2, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Adrenergic alpha-Antagonists
Tamsulosin
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013