A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting
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ClinicalTrials.gov Identifier: NCT00240812 |
Recruitment Status :
Completed
First Posted : October 18, 2005
Last Update Posted : June 29, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Enuresis | Drug: ibuprofen; pseudoephedrine HCl | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 318 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Comparative Study of Coadministered Doses of Ibuprofen and Pseudoephedrine HCl and Each Drug Alone in the Treatment of Primary Nocturnal Enuresis in Children |
Actual Study Completion Date : | November 2002 |

- The mean reduction in wet nights from the 14-day baseline period to the 14-day treatment period.
- The proportion of subjects with at least a 50% reduction in wet nights from baseline; the mean number of wet nights during the 14 days of treatment.

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Ages Eligible for Study: | 6 Years to 11 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject has nighttime bedwetting
- between the 5th and 95th percentiles for weight based on age and gender
- has a minimum of eight wet nights per 14 days of the baseline period
- healthy with no symptoms of any other complicating disease as determined by medical history review, physical examination, and clinical laboratory tests.
Exclusion Criteria:
- Subject has daytime urinary incontinence or abnormal bowel habits (i.e. fecal incontinence or constipation)
- has had episodes of dryness lasting one month or longer, at any time in the past
- has a medical condition which may be relevant to participation in the study
- has a known sensitivity or allergy to the study medications.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240812
Study Director: | McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00240812 |
Other Study ID Numbers: |
CR002497 |
First Posted: | October 18, 2005 Key Record Dates |
Last Update Posted: | June 29, 2011 |
Last Verified: | June 2011 |
nocturnal enuresis bedwetting ibuprofen |
Enuresis Urinary Incontinence Nocturnal Enuresis Urination Disorders Urologic Diseases Behavioral Symptoms Elimination Disorders Mental Disorders Lower Urinary Tract Symptoms Urological Manifestations Ibuprofen Pseudoephedrine Ephedrine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Anti-Asthmatic Agents Respiratory System Agents Nasal Decongestants Vasoconstrictor Agents |