A Phase 2 interventional study of SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg and 2 capsules Ibuprofen and 1 placebo in Sunburn, sponsored by Sephoris Pharmaceuticals LLC. Terminated at 1 site in Mauritius. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-27.
Sponsored by Sephoris Pharmaceuticals LLC · Phase 2, Interventional, and Treatment
A phase II multicenter, double-blinded clinical trial of the safety and efficacy of
SP160412 in the temporary relief of mild to moderate, (i.e. first degree) sunburn
The objectives of the trial or study, its endpoints, its assumptions and its variables are described below:
Objectives and endpoints Study objectives
The study intends to determine and compare the safety and synergistic efficacy of the combined dosing of Ibuprofen and Chlorpheniramine maleate vs. each of the individual drugs in subjects with mild to moderate ( 1st degree) sunburn.
29 studies on the registry are indexed under Sunburn; 2 are open to participants now.
This study's enrollment of 80 is above the median of 54 across 26 interventional studies indexed under Sunburn.
Browse Sunburn studies →This is the only study on the registry with Sephoris Pharmaceuticals LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
enter the study, a participant must meet all the following criteria:
Exclusion Criteria:
<!-- -->
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
oral route, 9 doses (Capsule) of SP160412 (Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg combined) in the 72 hours-period from first dose to last dose.
Drug: SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg
2 capsules Ibuprofen and 1 placebo, oral route, 9 doses of Ibuprofen 400 mg with Placebo (Capsule) in the 72 hours-period from first dose to last dose,
Drug: 2 capsules Ibuprofen and 1 placebo
capsule Chlorpheniramine 4mg and 1 Placebo, 3/72 hours-period from first dose to last dose, oral route
Drug: capsule Chlorpheniramine 4mg and 1 Placebo
Drug page: Chlorpheniramine
2 Ibuprofen and capsules Chlorpheniramine maleate 3 time per day for 72 hours
Also known as: 2 Capsules Ibuprofen and one capsules Chlorpheniramine
Ibuprofen and placebo
Also known as: Capsule with Ibuprofen 400 mg with Placebo
Chlorpheniramine 4mg and one capsule Placebo 3/72days
Also known as: Active comparator Chlorpheniramine 4 mg with Placebo
Self reported pain score on Pain Numeric Scale (NRS) at each visit
To measure the efficacy of SP160412 in the reduction of pain as reported by the participants. The Brief Pain Inventory - short version assesses pain in the last 24 hours and its impact on daily functioning. It evaluates the worst, the least, the average pain the participants felt during the last day and the actual pain. Scores range from 0 ("no pain") to 10 ("pain as bad as you can imagine"). BPI also evaluates the degree to which pain has interfered with different areas of participants' lives over the past 24 hours: general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven interference items, each of which is scored from zero ("does not interfere") to 10 ("completely interferes"). Finally, BPI also evaluates the amount of relief of pain treatments have provided in the past 24 hours, ranging from 0% ("no relief") to 100% ("complete relief").
Time frame: Twice a day (in the morning and at night) from day 1 to day 5
To measure the efficacy SP160412 combined with a placebo in the reduction of clinical sign of sunburn
To measure the efficacy of SP160412 on Pruritus. 11-point Itch NRS (Appendix I.3. Pruritus Numeric Rating Scale (NRS)); This instrument is presented as a single 11-point numeric scale with scores from 0 to 10, and anchored at 0 representing "No itch" and 10 representing "Worst imaginable itch"
Time frame: Twice a Day (in the morning and at night) from day 1 to day 5
To measure the efficacy of SP160412 for sleep quality
To measure the Sleep quality Scale using The 11-point(NRS)) is an unidimensional patient reported outcome (PRO) for quality of sleep. Participants will on a 11-point numeric rating scale ranging from 0 for "Best possible sleep" to 10 for "Worst possible sleep". Used on a daily basis, sleep diaries are reliable and valid instruments for capturing patient reported outcomes. The sleep quality NRS has good psychometric properties.single-item sleep quality NRS was correlated with pain.
Time frame: once a day in the morning from day 1 to 5
To evaluate the number of subject with adverse events
To evaluate the Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at evaluate the safety of SP160412 relative to each component alone combined with a placebo based on the incidence of treatment emergent Adverse Events will be recorded in the daily log by the participant and it will be documented at all evaluation visits. Overall incidence of adverse events will be collected for all days of evaluation, from Visit 0 (Day 0) to Visit 6 (Day 8).
Time frame: once a day from Days 2 to 8
Measurement of the evolution of erythema as measured by the Chromameter
To measure the evolution of erythema color by the use of a Chromameter
Time frame: at day one and visit at day 5
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Sep 2019, 20 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Chlorpheniramine