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NCT01167452 · ClinicalTrials.gov registry record · Phase 4

Effect of Weight and/or Obesity on Sulfamethoxazole and Trimethoprim Concentrations

A Phase 4 study, sponsored by Texas Tech University Health Sciences Center.

Completed
Registry status
Phase 4
Development phase
36
Enrollment target

NCT01167452: Completed Phase 4 study, sponsored by Texas Tech University Health Sciences Center.

NCT01167452 is a Phase 4 study that has completed, run by Texas Tech University Health Sciences Center. The registered enrollment target is 36 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01167452, a Phase 4 study, has completed, sponsored by Texas Tech University Health Sciences Center.

COMPLETED
Registry status
Phase 4
Development phase
36 participants
Enrollment target

Study Summary

This study will find how weight affects the dosing of a drug called sulfamethoxazole and trimethoprim. Currently, the amount of sulfamethoxazole and trimethoprim a patient receives is the same regardless of the patient's weight. The entire cohort was analyzed for the study outcomes. BMI groups were for recruitment purposes only and were not used for ordinal data analysis. All sulfamethoxazole and trimethoprim (Trade name is Bactrim or Septra) medication that you will receive in this study will be referred to as study medication within this informed consent form. This drug is a combination of two antibiotics, sulfamethoxazole and trimethoprim, which belongs to a class of medication known as "sulfones" and is approved by the US Food and Drug Administration (FDA) for the treatment of a wide variety of bacterial infections such as ear infections, urinary tract infections, bronchitis, traveler's diarrhea, and Pneumocystis carinii pneumonia. Sulfamethoxazole and trimethoprim is given orally.

Interventions

  • DRUG Sulfamethoxazole/trimethoprim

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2010-07
Est. Completion 2012-05
Phase Phase 4

What the finished NCT01167452 record still lists

NCT01167452 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which Sulfamethoxazole/trimethoprim is the first listed.

NCT01167452 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01167452 about?

NCT01167452 is a clinical study titled "Effect of Weight and/or Obesity on Sulfamethoxazole and Trimethoprim Concentrations". This study will find how weight affects the dosing of a drug called sulfamethoxazole and trimethoprim. Currently, the amount of sulfamethoxazole and trimethoprim a patient receives is the same regardless of the patient's weight. The entire cohort was analyzed for the study outcomes. BMI groups were ...

What is the current status of trial NCT01167452?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2010-07. Estimated completion is 2012-05.

What interventions are being tested in trial NCT01167452?

The interventions under investigation include: Sulfamethoxazole/trimethoprim (DRUG).

Who is sponsoring clinical trial NCT01167452?

This trial is sponsored by Texas Tech University Health Sciences Center, which has 76 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01167452's enrollment target sits among peer trials

36 1490th of 2000 higher than 495 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01167452, the US trial registry maintained by the National Library of Medicine. NCT01167452 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.