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NCT01062256
A Methodology Study to Assess Cough Counts in Subjects With Acute Upper Respiratory Tract Infections
NA trial testing Placebo in Infection in 265 participants. Completed in 1 February 2010.
1 February 2010
Quick facts
| Lead sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 265 |
| Start date | 1 January 2010 |
| Primary completion | 1 February 2010 |
| Estimated completion | 1 February 2010 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Placebo
- Guaifenesin (guaifenesin) — full drug profile →
- Buckwheat Honey — full drug profile →
Conditions studied
- Infection — all drugs for Infection →
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer — full company profile →
Who can join
18 and older, any sex, with Infection. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Cough Bouts Over 4-hour Postdose Period
Time frame: 0 to 4 hours postdose
Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.
Sponsor's own description
The objectives of this study are: a) to assess the feasibility and sensitivity of manually count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and severity of acute cough due to upper respiratory tract infection and c) to evaluate the correlation between cough bout frequency and subjective assessments of cough severity. The hypotheses to be tested is that 10 ml of buckwheat honey and 400 mg of immediate release guaifenesin will significantly reduce the frequency and severity of cough compared to placebo over a 4-hour evaluation period.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01062256
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT02879981 — A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis · completed
Other recruiting trials for Infection
Currently open trials in the same condition.
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- NCT06974162 — Metagenomics for Ocular Inflammation · recruiting
- NCT07370948 — Study of the Antibiotic-resistance Profile of Enterobacterales Isolated From Rectal Mucosal Buffer of PrEP Subjects · recruiting
Other Wyeth is now a wholly owned subsidiary of Pfizer trials
Trials by the same sponsor.
- NCT00909688 — Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses · Phase 1 · completed
- NCT00853749 — Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine · Phase 3 · completed
- NCT00894634 — Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents · Phase 1 · completed
- NCT00854009 — Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects · Phase 1 · completed
- NCT00837837 — Study Evaluating Chlorpheniramine Maleate Liquid in Children and Adolescents · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01062256 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wyeth is now a wholly owned subsidiary of Pfizer
- Last refreshed: 20 February 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01062256.
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