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A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain

NCT03877718 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2019-11-01

No results posted yet for this study

Summary

A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain.

Conditions

Interventions

DRUG

Arm 1: CL-H1T

One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 18.75 mg)

DRUG

Arm 2: CL-H1T

One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 37.5 mg)

DRUG

Arm 3: Sumatriptan Succinate 100 mg capsule

One capsule of sumatriptan succinate 100 mg

DRUG

Arm 4: Promethazine HCl 18.75 mg

One capsule of promethazine HCl 18.75 mg

DRUG

Arm 5: Promethazine HCl 37.5 mg

One capsule of promethazine HCl 37.5 mg

OTHER

Placebo

One capsule of placebo

Sponsors & Collaborators

  • Charleston Laboratories, Inc

    lead INDUSTRY

Principal Investigators

  • Bernard P. Schachtel, MD · Charleston Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2019-08-27
Completion
2019-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03877718 on ClinicalTrials.gov