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CompletedNCT02839135Updated May 18, 2018

A Comparative Bioavailability and Adhesion Performance Study, Comparing a New Scopolamine Transdermal Delivery System Formulation to the Currently Established Reference Transdermal Delivery System in Healthy Adult Participants.

A Phase 1 interventional study of Reformulated scopolamine patch and Marketed scopolamine patch in Motion Sickness, sponsored by GlaxoSmithKline. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-18.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

In this comparative bioavailability and in vivo skin adhesion study, the impact of minor changes in qualitative composition of polyiso-Butylenes (PIB) from a different supplier and change of the manufacturing line of the micro porous membrane will be tested.

Read the detailed description

This study is a randomized, single-center, cross-over, comparative bioavailability and adhesion study, comparing single administrations of a new scopolamine transdermal delivery system formulation to the current established reference transdermal delivery system in healthy adult participants. The study will consist of an ambulant screening day within 21 days prior to the first investigational medicinal product (IMP) administration at study Day 1 and two treatment periods. Each treatment period will consist of 4.5 days (108 hours) of in-house confinement.

02

Conditions studied

  • Motion Sickness

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03

In context

Motion Sickness

50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.

This study's enrollment of 128 is above the median of 59 across 44 interventional studies indexed under Motion Sickness.

Browse Motion Sickness studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Participants must understand and provide written before any assessment is performed, understand the study procedures, and be willing and able to complete the required assessments.
  • Male or female participants of any ethnic origin, and aged from 18 to 55 years (inclusive).
  • between 18 and 30 kg/m2.
  • Normal vital signs as follows: Oral body temperature between 35.0 and 37.5 ºC (95 and 99.5 °F) inclusive; Supine systolic blood pressure between 90 and 140 mmHg inclusive; Supine diastolic blood pressure between 55 and 90 mmHg inclusive;Pulse rate between 50 and 100 beats per minute (bpm) inclusive.
  • In general good physical health including the presence of healthy and non irritated skin at test site behind the participant's ears, as judged by the investigator and determined by medical/surgical history, physical examination, (ECG) (12-lead), and clinical laboratory (clinical chemistry, hematology and urinalysis).
  • Ability to communicate and comply with all study requirements.
  • Willingness and ability to complete the study.

Exclusion criteria

Exclusion Criteria:

  • Presence of tattoo, hair (including shaved hair) or scarring on the test site behind the participant's left or right ear.
  • Surgical procedures or use of topical pharmacologic treatments directly over the test site(s) within 90 days before enrollment.
  • Use of other belladonna alkaloids, antihistamines, tricyclic antidepressants (such as amitriptyline and imipramine), amantadine, quinidine within 2 weeks prior to the first scheduled study drug administration.
  • Participation in a previous clinical study with another product within the last 90 days or use of other investigational drugs within 90 days or 10 half-lives before enrollment, whichever is longer.
  • History of or known or photosensitivity to any of the study drugs, or to drugs of similar chemical classes.
  • Diagnosis of angle-closure (narrow angle) glaucoma.
  • History or current evidence of pyloric obstruction, intestinal obstructions or urinary bladder neck obstruction (e.g. due to benign prostate hyperplasia) and History of seizures or psychosis.
  • Diagnosis of long syndrome or QTc > 450 millisecond (msec) for males and > 470 msec for females at screening.
  • History of or neoplastic disease of any organ system (except for localized basal cell skin carcinoma), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or .
  • Pregnant, nursing (lactating) women.
  • Women of , defined as all women physiologically capable of becoming pregnant unless they are: women whose career, lifestyle or sexual orientation precludes intercourse with a male partner, at the judgment of the investigator; women who have been surgically sterilized or whose partners have been sterilized by vasectomy or other means; using a highly effective method of (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs). Double barrier and periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable means of contraception; A woman who is must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child bearing potential if they had 12 months of natural (sp ntaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with known or reported serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks before. In the case of oophorectomy alone, women are considered post-menopausal only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance.
  • History of hypertension, cardiovascular disease, stroke or (TIA).
  • History of orthostatic hypotension, fainting or blackouts.
  • chronic or acute infectious illnesses or febrile infections within two weeks prior to start of the study.
  • History within the last five years or current evidence of pulmonary, gastrointestinal, hematological, endocrinological, metabolic, , neurological, psychiatric or other diseases at screening unless deemed medically insignificant or clinically insignificant as assessed by the Investigator.
  • Clinically significant laboratory findings at screening such as anemia ( \<11.5 g/dL for women and \<13.5 g/dL for men), serum potassium \<3.5 mmol/L or >5.0 mmol/L, or serum sodium \<132 mmol/L or >150 mmol/L.
  • Use of any medication within 2 weeks before first scheduled study drug administration or within less than 10 times the elimination half-life of the respective drug (whichever is longer), or is anticipated to require any concomitant medication during that period or at any time throughout the study.
  • Any history of asthma, urticaria, or other significant allergic diathesis. Participants with uncomplicated seasonal allergic rhinitis can be accepted if expected allergy season is clearly outside enrolment/ treatment period.
  • Participant has a history of illicit drug abuse or investigator has evidence of current drug abuse with drug classes that include but are not limited to barbiturates, tricyclic antidepressants, amphetamines, benzodiazepines, cocaine, opiates, cannabis or any other illicit drugs (verified by urine drug screen or other reliable evidence).
  • Smokers or evidence for current alcohol abuse or reports a regular average alcohol consumption exceeding 18 g (women) or 35 g (men) of pure alcohol per day, i.e. 1 drink/day for women or or 35 g (men) of pure alcohol per day, i.e. 1 drink/day for women or 2 drinks/day for men (1 drink = 5 oz of wine or 12 oz of beer or 1.5 oz of hard liquor) within 6 months of screening.
  • Positive results in any of the virology tests for Antibodies (HIV-Ab), Antibodies Virus (HCV-Ab), Surface antigen of (HBsAg) and HBc-Ab (Immunoglobulin G [IgG] +Immunoglobulin M [IgM]).
  • Performance of unaccustomed strenuous physical exercise (body building, high performance sports) from 2 weeks prior to start of the study and throughout the entire study.
  • Allergy to skin disinfecting agents, tape, or latex rubber.
  • Any condition not identified in the protocol that in the opinion of the Investigator would confound the evaluation and interpretation of the study data or may put the participant at risk.
  • Previously enrolled in the current study.
  • "Vulnerable" individual.
  • Participation in a clinical trial with at least 470mL blood drawn, or blood donation within 12 weeks prior to the start of the study.
  • Not willing to fully comply with the following lifestyle restrictions throughout the study.
  • Participation in a clinical trial with at least 470mL blood drawn, or blood donation within 12 weeks prior to the start of the study.
Terms in these criteria, in plain language(19)

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.

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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.

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.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
128 participants (actual)

Study arms

  • Experimental
    Reformulated scopolamine patch

    Participants will receive reformulated scopolamine Transdermal Delivery System (TDS) patch 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area with delivery of approximately 1.0 mg over 72 hours.

    Drug: Reformulated scopolamine patch

  • Active comparator
    Marketed scopolamine patch

    Participants will receive currently marketed scopolamine TDS patch 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area, with delivery of approximately 1.0 mg over 72 hours.

    Drug: Marketed scopolamine patch

Interventions

  • DrugReformulated scopolamine patch

    Reformulated scopolamine patch of 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area with deliver approximately 1.0 mg over 72 hours

  • DrugMarketed scopolamine patch

    Marketed scopolamine patch of 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area with delivery of approximately 1.0 mg over 72 hours.

06

What researchers measure

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    The maximum observed post-dose concentration.

    Time frame: upto 96 hours

  2. Area under the curve from time zero extrapolated to infinity [AUC(0-inf)]

    The area under the plasma concentration versus time curve will be calculated from time 0 to infinity.

    Time frame: upto 96 hours

  3. Area under the curve from time zero to last sampling time [AUC(0-t)]

    The area under the plasma concentration versus time curve will be calculated from time 0 to the last measurable sampling time point, t.

    Time frame: upto 96 hours

  4. Time to reach maximum plasma concentration (Tmax)

    The time of the maximum observed post-dose concentration.

    Time frame: upto 96 hours

  5. Termination rate constant (Lambda_z)

    The terminal elimination rate constant.

    Time frame: upto 96 hours

  6. Percentage area under the curve by extrapolation (%AUCex)

    Percentage of AUC0-inf obtained by extrapolation.

    Time frame: upto 96 hours

  7. Elimination half life (t1/2)

    The elimination half-life.

    Time frame: upto 96 hours

  8. Patch adherence assessment

    Patch adherence evaluation will be performed.

    Time frame: upto Day 4

Secondary outcomes

  1. Skin Irritation

    Skin irritation will be assessed at 0.5 hour and 24 hours after patch removal in each study period.

    Time frame: After 0.5 hour, 24 hours

  2. Safety Assessment

    Safety assessments will consist of evaluation of skin for irritation, monitoring and recording of all adverse events including serious adverse events, physical examination, vital signs (including blood pressure, pulse rate and body temperature), laboratory tests.

    Time frame: upto Day 16

07

Study locations

1 site
  • GSK Investigational Site
    Mont Royal, QC, Quebec H3P 3E5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02839135
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 20, 2016
Start date
May 13, 2016
Primary completion
Aug 1, 2016
Completion
Aug 10, 2016
Last update
May 18, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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