Motion SicknessPhase 1NCT02839135
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 study testing Reformulated scopolamine patch and Marketed scopolamine patch in people with Motion Sickness, run by GlaxoSmithKline at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Motion Sickness
- What is being tested?
- Reformulated scopolamine patch and Marketed scopolamine patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- 13 May 2016to 10 Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must understand and provide written informed consent 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).
- Body mass index 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, electrocardiogram (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.
Who cannot join
- 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 investigational 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 hypersensitivity or photosensitivity to any of the study drugs, excipients or to drugs of similar chemical classes.
- Diagnosis of angle-closure (narrow angle) glaucoma.
Show all 30Show fewer
- 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 QT syndrome or QTc > 450 millisecond (msec) for males and > 470 msec for females at screening.
- History of malignancy 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 metastases.
- Pregnant, nursing (lactating) women.
- Women of child-bearing potential, 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 birth control (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 postmenopausal 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 Transient Ischemic Attack (TIA).
- History of orthostatic hypotension, fainting or blackouts.
- Clinically relevant 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, autoimmune, 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 (hemoglobin <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 Human Immunodeficiency Virus Antibodies (HIV-Ab), Antibodies Hepatitis C Virus (HCV-Ab), Surface antigen of Hepatitis B (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-center, Crossover, Comparative Bioavailability and Adhesion Performance Study, Comparing Single Administrations of a New Scopolamine Transdermal Delivery System Formulation to the Currently Established Reference Transdermal Delivery System in Healthy Adult Participants.
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.
- Conditions
- Motion Sickness
- Being tested
- Reformulated scopolamine patch, Marketed scopolamine patch
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reformulated scopolamine patchDrug
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
Marketed scopolamine patchDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Reformulated scopolamine patch | Experimental | 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. Receives: Drug: Reformulated scopolamine patch |
| Marketed scopolamine patch | Active comparator | 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. Receives: Drug: Marketed scopolamine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
The maximum observed post-dose concentration.
Measured: upto 96 hours
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.
Measured: upto 96 hours
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.
Measured: upto 96 hours
Time to reach maximum plasma concentration (Tmax)
The time of the maximum observed post-dose concentration.
Measured: upto 96 hours
Termination rate constant (Lambda_z)
The terminal elimination rate constant.
Measured: upto 96 hours
Percentage area under the curve by extrapolation (%AUCex)
Percentage of AUC0-inf obtained by extrapolation.
Measured: upto 96 hours
Elimination half life (t1/2)
The elimination half-life.
Measured: upto 96 hours
Patch adherence assessment
Patch adherence evaluation will be performed.
Measured: upto Day 4
Secondary outcomes (2)
Skin Irritation
Skin irritation will be assessed at 0.5 hour and 24 hours after patch removal in each study period.
Measured: After 0.5 hour, 24 hours
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.
Measured: upto Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start13 May 2016
- Primary completion1 Aug 2016
- Study completion10 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motion SicknessStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839135
- Sponsor's protocol ID
- 205035
- Status last verified
- May 2018
- First submitted
- 18 Jul 2016
- Last updated
- 18 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-center, Crossover, Comparative Bioavailability and Adhesion Performance Study, Comparing Single Administrations of a New Scopolamine Transdermal Delivery System Formulation to the Currently Established Reference Transdermal Delivery System in Healthy Adult Participants.
- ClinicalTrials.gov ID
- NCT02839135
- Acronym / sponsor ID
- 205035
- Conditions
- Motion Sickness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 May 2016 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 10 Aug 2016 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reformulated scopolamine patch | Experimental | Drug: Reformulated scopolamine patchParticipants 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. |
| Marketed scopolamine patch | Active comparator | Drug: Marketed scopolamine patchParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants must understand and provide written informed consent 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).
- Body mass index 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, electrocardiogram (ECG) (12-lead), and clinical laboratory (clinical chemistry, hematology and urinalysis).
Key exclusion criteria (30 listed)
- 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 investigational 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 hypersensitivity or photosensitivity to any of the study drugs, excipients or to drugs of similar chemical classes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reformulated scopolamine patchReformulated 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 | Drug | Reformulated scopolamine patch |
| Marketed scopolamine patchMarketed 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. | Drug | Marketed scopolamine patch |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: upto 96 hours
The maximum observed post-dose concentration.
Area under the curve from time zero extrapolated to infinity [AUC(0-inf)]
Time frame: upto 96 hours
The area under the plasma concentration versus time curve will be calculated from time 0 to infinity.
Area under the curve from time zero to last sampling time [AUC(0-t)]
Time frame: upto 96 hours
The area under the plasma concentration versus time curve will be calculated from time 0 to the last measurable sampling time point, t.
Time to reach maximum plasma concentration (Tmax)
Time frame: upto 96 hours
The time of the maximum observed post-dose concentration.
Termination rate constant (Lambda_z)
Time frame: upto 96 hours
The terminal elimination rate constant.
Percentage area under the curve by extrapolation (%AUCex)
Time frame: upto 96 hours
Percentage of AUC0-inf obtained by extrapolation.
Elimination half life (t1/2)
Time frame: upto 96 hours
The elimination half-life.
Patch adherence assessment
Time frame: upto Day 4
Patch adherence evaluation will be performed.
2 secondary outcomes
Skin Irritation
Time frame: After 0.5 hour, 24 hours
Safety Assessment
Time frame: upto Day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Results for Study 205035 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Reformulated scopolamine patch and Marketed scopolamine patch in people with Motion Sickness, run by GlaxoSmithKline at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) (time frame: upto 96 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018; AzTrials last refreshed its copy on 27 Oct 2026.