NCT03415243

To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers

Completed Phase 1 Results posted Last updated 24 June 2019

What this trial tests

Phase 1 trial testing Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg in Common Cold in 28 participants. Completed in 29 March 2018.

Timeline

1 March 2018

Primary endpoint
29 March 2018

29 March 2018

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	1 March 2018
Primary completion	29 March 2018
Estimated completion	29 March 2018
Sites	1 location across United States

Drugs / interventions tested

• Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg — full drug profile →
• Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg — full drug profile →

Conditions studied

• Common Cold — all drugs for Common Cold →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 21 to 45, male only, with Common Cold. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Time to Onset of Gastric Emptying Primary · Predose until 10 hours post dose on Day 1

Mean time to onset of gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 microcurie \[mcCi\] isotope-technetium-99m-diethylene-triamine-pentaacetate \[DTPA\]). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. Regions of interest (ROI) included the stomach, proximal small intestine, distal small intestine and colon.

Group	Value	95% CI
Treatment Group A	1.107	± 1.2130
Treatment Group B	8.534	± 6.6062

Mean Time to Complete Gastric Emptying Primary · Predose until 10 hours post dose on Day 1

Mean time to complete gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m-DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.

Group	Value	95% CI
Treatment Group A	121.2	± 47.76
Treatment Group B	65.3	± 47.40

Mean Time for Gastric Emptying by Measuring 25 Percent Values Primary · Predose until 10 hours post dose on Day 1

Mean time to gastric emptying by 25 percent (GE25%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.

Group	Value	95% CI
Treatment Group A	12.614	± 6.8249
Treatment Group B	12.171	± 9.1819

Mean Time for Gastric Emptying by Measuring 50 Percent Values Primary · Predose until 10 hours post dose on Day 1

Mean time to gastric emptying by 50 percent (GE50%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.

Group	Value	95% CI
Treatment Group A	22.643	± 11.4058
Treatment Group B	16.134	± 11.8721

Mean Time for Gastric Emptying by Measuring 90 Percent Values Primary · Predose until 10 hours post dose on Day 1

Mean time to gastric emptying by 90 percent (GE90%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.

Group	Value	95% CI
Treatment Group A	84.929	± 43.1606
Treatment Group B	36.214	± 33.7711

Percentage of Radiolabeled Drug Remaining in the Stomach After 15 Minutes of Administration Primary · 15 minutes post dose on Day 1

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 15 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.

Group	Value	95% CI
Treatment Group A	67.00	± 13.260
Treatment Group B	49.77	± 42.193

Percentage of Radiolabeled Drug Remaining in the Stomach After 30 Minutes of Administration Primary · 30 minutes post dose on Day 1

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 30 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.

Group	Value	95% CI
Treatment Group A	33.24	± 19.321
Treatment Group B	20.87	± 26.697

Percentage of Radiolabeled Drug Remaining in the Stomach After 45 Minutes of Administration Primary · 45 minutes post dose on Day 1

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 45 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.

Group	Value	95% CI
Treatment Group A	24.79	± 16.334
Treatment Group B	7.21	± 11.387

Percentage of Radiolabeled Drug Remaining in the Stomach After 60 Minutes of Administration Primary · 60 minutes post dose on Day 1

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 60 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.

Group	Value	95% CI
Treatment Group A	20.07	± 13.885
Treatment Group B	4.26	± 10.378

Percentage of Radiolabeled Drug Remaining in the Stomach After 75 Minutes of Administration Primary · 75 minutes post dose on Day 1

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 75 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.

Group	Value	95% CI
Treatment Group A	14.73	± 13.350
Treatment Group B	3.28	± 8.123

Percentage of Radiolabeled Drug Remaining in the Stomach After 90 Minutes of Administration Primary · 90 minutes post dose on Day 1

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 90 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.

Group	Value	95% CI
Treatment Group A	8.84	± 9.867
Treatment Group B	2.45	± 6.164

Percentage of Radiolabeled Drug Remaining in the Stomach After 105 Minutes of Administration Primary · 105 minutes post dose on Day 1

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 105 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.

Group	Value	95% CI
Treatment Group A	6.06	± 8.145
Treatment Group B	1.72	± 5.279

Adverse events — posted to ClinicalTrials.gov

Time frame: From signature of informed consent form up to 5 days after last administration of the investigational product (up to Day 6). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Group A

Serious: 0/14 (0%)

Deaths: 0/14

Treatment Group B

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (4 terms — click to expand)

Reaction	System	Treatment Group A	Treatment Group B
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Alanine aminotransferase increased	Investigations	—	—

Data from ClinicalTrials.gov NCT03415243 adverse events section.

Sponsor's own description

This clinical study will be conducted to characterize the gastrointestinal transit of two multi-symptoms formulations by inclusion of a radiolabel marker.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A single-dose, open-label, randomized, scintigraphic study to investigate the gastrointestinal behavior of 2 triple-combination cold products (acetaminophen, phenylephrine, and dextromethorphan) in healthy male volunteers.
   Mallefet P, Armogida M, Doll WJ, Page RC, et al · · 2022 · PMID 35135601 · DOI 10.1186/s13063-022-06037-x